State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars

Richard Cauchi 10/22/2018

injectionsFor several decades, every state has regulated the use of brand-name and generic prescription drugs through statutes and agency or board rules. These state actions include when and how generics may be substituted for brand-name prescriptions, by pharmacists or others. Generic drugs typically have active ingredients that are identical to those of their brand-name counterpart. These traditional drugs include familiar pills used regularly by tens of millions of Americans as well as some specialty drugs.

Biologic medicines are much more complex than traditional chemically synthesized drugs. Biologics are manufactured from living organisms by programming cell lines to produce the desired therapeutic substances and consist of large molecules. Common biologics in use today include injectable treatments for arthritis, medicines for cancer, diabetes, Crohn's disease, psoriasis, the Hepatitis B vaccine and pending stem cell therapies.

Regulating biologics raises new issues for both state and federal policymakers. Because of their complexity, biologic drugs are much more difficult to replicate than the chemically produced generics for other drugs. The cell lines used and modifications in the manufacturing process affect biologic medicines. As a result, truly identical “generic” versions are currently virtually impossible to produce. However, once patents expire for the existing brand-name biologic drugs, “biosimilar” medicines can be produced, which is an occurrence that raises regulatory issues in the states.

Currently, there is concern that traditional statutes regulating “generic drugs” may be misapplied to new products that are not identical. This has led to a recent move to amend older state laws to address the medical and chemical characteristics of these “biologics,” as well as any future generic-style “follow-on biologics” or “biosimilars.”  

FDA News: Scott Gottlieb, FDA Commissioner, March 7, 2018, stated, "Payors can also help us by doing more to educate clinicians about the safety and value of biosimilars, to encourage appropriate adoption. We’ll know that we’ve been successful when there’s a biosimilar market that can sustain multiple competing biosimilar and biologic options. [More]
 

In the past five years a cumulative total of at least 49 states have considered legislation establishing state standards for substitution of a “biosimilar” prescription product to replace an original biologic product.

Biosimilar Substitution Requirements State Law & Legislation Tally

  • After five years of legislative filing, debate and votes the cumulative total shows laws in 45 states and Puerto Rico.
  • In 2013-14, eight states enacted the first round of such biologics and biosimilars laws. (Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah and Virginia)
  • In 2015-16, of those filed, 17 more state laws have been signed, in Arizona (5/12/2016), California (10/6/2015), Colorado, Georgia, Hawaii, Idaho (3/24/2016) Illinois, Kentucky (4/11/2016), Louisiana, Minnesota, Missouri (6/8/2016), New Jersey (11/9/2015), North Carolina, Pennsylvania (7/20/2016), Rhode Island (2016), Tennessee, Texas, Utah, Washington and Puerto Rico. In addition Minnesota has a limited purpose law restricting substitution related to "fail-first" state policies.
  • In 2017 laws were signed in 11 more states. Iowa (3/5/2017), Kansas, Maryland, Minnesota, Montana (2/22/2017), Nebraska, Nevada, New Mexico, New York, Ohio and South Carolina. 
  • In 2018 so far nine states, Alaska (6/2018), Connecticut, Michigan (2/28/2018), New Hampshire,  South Dakota (2/8/2018), Vermont (5/30/2018), West Virginia (3/16/2018), Wisconsin (3/27/2018) and Wyoming (3/28/2018) each enacted such a law.
    • Maine enacted a first-in-the nation law (2018) to speed the development of biosimilars by requiring manufacturers to share the originator product.

US Map of Biologics and Biosimilar substitution legislationMap: latest additions AK, CT, ME, NH

Prescription Drug Database: Use NCSL's updated 2015-2018 state legislative database to learn about and analyze what states are considering and enacting in 10 current topic areas of prescription drugs. The 3,600+ bill listings for these four years include a check-box search category for "biologics and biosimilars" as well as other topics of interest such as state roles in regulating safety and compounding, specialty drugs and clinical trial and 'right-to-try' measures.

Typical Features of State Legislation 2013-2018

The provisions of state legislation vary, but there are several features and requirements that frequently are included:

  • FDA Approval: Any biological product under consideration for substitution must first be approved as "interchangeable" by the U.S. Food and Drug Administration or FDA.  (Three products have gained full FDA approval as a biosimilar (but not yet interchangeable) in the United States, as of November 2016)
  • Prescriber Decides: The prescriber (such as a physician, oncologist, physician assistant, etc.) would be able to prevent substitution by stating “dispense as written” or “brand medically necessary.”
  • "Notification" vs "Communication:" In bills enacted in 2013-2014, the language usually required that the prescriber "must be notified" of any allowable substitution made at a pharmacy. In 2015 bills the language commonly has been adjusted to say "communicate with," allowing a notation in an electronic medical record (EMR), PBM records or "pharmacy record that can be electronically accessible by the prescriber."  (This would allow a physician to assess and compare the patient experience, but not delay the transaction.)
  • Patient Notified? The individual patient must be notified that a substitute or switch has been made; this provision is included in at least 20 states. In some cases, state law would require patient consent before any such switch is made. (Some consumer experts note that proving notification or consent may discourage use of an approved biosimilar.)
  • Records: The pharmacist and the physician must retain records of substituted biologic medications for a certain period of time, such as two or three years.
  • Immunity: Some state legislation provides legal immunity for pharmacists who make a substitution in compliance with biologics state law.
  • Web Lists: The state must maintain a public or web-based list of FDA approved interchangeable products.
  • Cost or Pricing: Some legislation requires the pharmacist to explain the cost or price of the biologic and the interchangeable biosimilar. The enacted laws in Colorado, Georgia, Illinois, North Carolina and Texas require that any authorized or allowable substitution must have the lowest cost.

2015-18 News

  • Biosimilar Cost Savings in the United States. Rand study: "
    We estimated the cost savings potential of biosimilars to be $54 billion over ten years using recent baseline data and transparent assumptions, with a lower- to upper-bound range of $25 billion to $150 billion. Actual savings will hinge on an evolving biosimilar regulatory and competitive landscape." [Rand study, 2017]
  • First U.S. Biosimilar Drug is Launched. "Years after discounted versions of some of the most expensive drugs ever went on sale in other countries, they’re finally coming to the world’s biggest medicine market.  AP reported that on Sep. 3, 2015 "Swiss drugmaker Novartis AG launched Zarxio, a biosimilar version of Amgen Inc.’s Neupogen, which boosts white blood cell production to prevent infections in certain cancer and other patients." Prices are not yet announced, but are projected to be 15-30 percent lower than the original.  Market research firm GBI Research reports at least 150 "copycat" biosimilars are in development this year. [Read full article] published in Washington Post, 9/10/2015.  
  • HHS/CMS Releases Guidance for the Role of Medicaid programs.  On March 30, 2015, the Centers for Medicare and Medicaid Services issued a guidance fact sheet that sets a framework by “issuing guidance to states on the classification of biosimilar biological products for rebate purposes and on strategies for states to use these products to reduce costs while improving access in terms of state Medicaid preferred drug lists.
          The CMS release emphasizes pricing and savings, saying, “State Medicaid programs should view the launch of biosimilar biological products as a unique opportunity to achieve measurable cost savings and greater beneficiary access to expensive therapeutic treatments for chronic conditions. States and managed care organizations are encouraged to provide biologics that achieve desirable, cost-effective clinical outcomes for beneficiaries using the various drug utilization and cost management tools they have available (e.g., step therapy, prior authorization, preferred drug lists).  See: Biosimilars and the Medicaid Drug Rebate Program, Release 92. 3/30/2015.
  • FDA Approves 2nd, Cheaper Version Of Biologics (J&J’s Top Drug Remicade): (From Washington Post 4/6/2016)
    Federal health officials have approved a cheaper version of Johnson & Johnson’s blockbuster drug, Remicade, a high-priced biotech medicine for inflammatory diseases. The approval of Inflectra on April 5, 2016 "is only the second time that the Food and Drug Administration has approved a quasi-generic biotech drug for the U.S. market. These so-called biosimilar drugs, already available in Europe, have the potential to generate billions of dollars in savings for insurers, doctors and patients in coming years."
  • Breast Cancer Biosimilar Approval. On Dec. 1, 2017 the U.S. FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.
  • List of Licensed Biological Products with Biosimilarity or Interchangeability Evaluations to Date: As of Dec. 31, 2017, there are eight or nine bio-similars approved by the FDA for use in the United States. They are not currently designated as interchangeable at the prescription/retail level, so none of the state laws can be applied to dispensing decisions. Cost per month examples include prices from Good Rx and are meant as approximate comparisons not necessarily prices available in a particular location or treatment setting.

List of Licensed Biological Products with Biosimilarity or Interchangeability Evaluations to Date

(“FDA PROPER)” PRODUCT NAME

BRAND/ PROPRIETARY NAME ®

DATE OF FDA LICENSURE (mo/day/yr)

BIOSIMILAR (B)

INTER-CHANGEABLE (I)

Treatment, major

Cost / month examples
(retail includes discounts)

Manufacturer / Notes

adalimumab

Humira

12/31/02

Original

no

Rheumatoid and psoriatic arthritis

$4,537 (2 pens)

Abbvie

adalimumab-adbm

Cyltezo

08/25/17

Biosimilar

no

Rheumatoid and psoriatic arthritis *

Not available - patent litigation

Boehringer Ingelheim

patent litigation v Abbvie

adalimumab-atto

Amjevita

09/23/16

Biosimilar

no

Rheumatoid and psoriatic arthritis; Crohn’s disease, etc.*

Not available “launch in 2017 was unlikely due to patent issues” (9/5/2017)

Amgen

bevacizumab Avastin 02/26/2004 Original no Cancers: Metastatic colorectal; cervical, etc $675 (4 ml) -
$2700 (16 ml vial)
Genentech Inc.
bevacizumab-awwb Mvasi 9/14/2017; 12/21/2017 Biosimilar no Cancers: Metastatic colorectal; cervical, etc Not available Amgen Inc
 

etanercept

Enbrel

11/02/98

Original

no

Active rheumatoid arthritis; plaque psoriasis

$4,537.83 retail

Amgen

etanercept-szzs

Erelzi

08/30/16

Biosimilar

no

Active rheumatoid arthritis; plaque psoriasis

Not available -legal challenges

Sandoz/Novartis. 

Legal challenges/delay

filgrastim

Neupogen

02/20/91

Original

no

Cancer/chemo/radiation effects

$4100 12-syringes retail

Amgen

filgrastim-sndz

Zarxio

03/06/15

Biosimilar

no

Cancer/chemo/radiation effects

$3400 12-syringes retail

Sandoz/ Novartis

infliximab

Remicade

08/24/98

Original

no

Crohn's disease, ulcerative colitis. psoriasis, arthritis

$1200 1 vial

Janssen Biotech/ Johnspn & Johnson

infliximab-abda

Renflexis

04/21/17

Biosimilar

no

Crohn’s disease, arthritis, and psoriasis (FDA release)

$735 for 100 milligram dose. Limited availability

Samsung Bioepsis; fifth biosimilar to be approved in the US

infliximab-dyyb

Inflectra

04/05/16

Biosimilar

no

Crohn’s disease, arthritis, and psoriasis (FDA release)

$945 1 vial. “share: 2.3% of the overall infliximab volume,” Total US revenue = $23 million, 2nd ¼ 2017

Pfizer Biosimilars. second biosimilar to be approved in the US

trastuzumab Herceptin 10/20/2010 Original no Breast or metastatic stomach cancer $4,456.34 1 vial Genentech, Inc
trastuzumab-dkst Ogivri 12/1/2017 Biosimilar no

Breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma)

(FDA release)

new release, not yet on sale

Mylan GmbH.

Second biosimilar to be approved for cancer

Source: FDA Center for Drug Evaluation and Research: List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date (Accessed 8/30/2017). FDA approval dates include information from  https://www.drugs.com/history.

Presentation at NCSL Legislative Roundtable on Biologics Innovation by BIO VP David Thomas - June 8, 2016

Biologics and Biosimilar Substitution: 2013-2018 State Laws

State

Citation | Bill Number | Lead Sponsor

Summary | Description
(The brief summaries reproduced below are not intended to describe all statutory provisions – see full text for further information)

FDA Must Certify
Interchan­geability

Prescriber / Doctor
 "Notification" or "Communication"

Patient Notification

Prescriber’s “Brand Medically Necessary” Blocks Substitution

Pharmacy Records Must Be Retained

Posted List of Interchan­geables

ENACTED LAWS

 

 

 

 

 

 

 

Alaska

SB 32, signed 7/13/2018; 

Sponsor: Sen. Highes (R-F)

Relates to biological products and the practice of pharmacy. Substitution of an interchangeable biologic is permitted only if the prescriber does not personally indicate that a substitution is not to be made. Requires a pharmacist to make an electronically accessible entry in a patient record system; requiring the Board of Pharmacy to post a link to the U.S. FDA's list of all currently approved interchangeable biological product.

Yes

Yes

3 days

No Yes

Yes

2 years

Yes

Arizona

H 2310

Signed 5/17/2016 as Act No. 293

Allows a pharmacist to substitute a biological product for a prescribed biological if certain conditions are met, including a requirement that the pharmacy inform the patient of the substitution and a requirement that the pharmacy retain a record, requires notification of any price difference, 

Yes

Yes

5 days
(Communication)

Yes

Yes

Yes

Yes

California

S 671;

Signed 10/6/2015.
Sponsor: Sen. Hill (D)

Authorizes a pharmacist to select an alternative biological product when filling a prescription order for a prescribed biological product if the alternative biological product is designated interchangeable by the FDA and the prescriber does not personally indicate that a substitution is not to be made. Requires a pharmacist to make an electronically accessible entry in a patient record system of the specified biological product provided to the patient, also provides an alternative record method.

Yes

Yes

5 days
(Communication)

Yes

Yes

Yes

Yes

Colorado

S 71; Signed 4/3/2015; 

Sponsor: Sen.Jahn (D)

(See Rx Database, keyword "Biologics" for specifics.) Allows a pharmacist to substitute a biological product if the FDA has determined that the biological product is interchangeable with the prescribed biological product and if the practitioner has not indicated that the prescription must be dispensed as written, provides the dispensing pharmacist or the pharmacist's designee must communicate to the prescribing practitioner the specific biological product dispensed to the patient, provides situations when communication is not necessary. Yes Yes Yes Yes

Yes

2 years

Yes
Connecticut

SB 197; signed 2018;

Sponsor: Witkos (R), Tercyak (D)

 

Concerns biological products; adds biological products to existing law regarding substitution of generic drugs. Requires that within 48-hours of dispensing ''the pharmacist shall inform the prescribing practitioner by facsimile, telephone or electronic transmission of the biosimilar substitution.'' Yes

Yes 

3 days
 

Yes Yes

Yes

3 years

No

Delaware

S 118; Ch. 238, signed 5/28/2014

Sponsor: Sen. Poole (D)

Authorizes pharmacists to substitute FDA-approved interchangeable biosimilar biological products for prescribed biological reference products with specified safeguards. To substitute a biosimilar product, pharmacists must notify the patient and prescriber in writing; the authorized prescriber did not state expressly that the prescription is to be dispensed only as directed; record information on the label and dispensing record; and maintain a three year record of such substitutions. Also provides liability protections for pharmacists who substitute biosimilars.

Yes

Yes

(Notification)

Yes
in writing

Yes

Yes

3 years

No

Florida

H 365; Ch. 2013-102; signed 6/3/2013
Sponsor: Rep. Matt Hudson (R)

Relates to pharmacy substitutions. Provides requirements for pharmacist to dispense substitute biological product, requiring the FDA to have determined substitute biological product is "biosimilar to and interchangeable for prescribed biological product. The prescribing provider must not "express a preference against substitution. "The pharmacist must notify the patient or person at the counter of the substitution and substitution record retained for two years. Also requires the state Board of Pharmacy to maintain current list of interchangeable biosimilar products. Effective as of July 1, 2013.

Yes

Yes
(under existing provisions) 

Yes

Yes

Yes
2 years

Yes

Georgia

S 51

Signed 5/6/2015

Sponsor: Sen. Burke (R)

(See Rx Database, keyword "Biologics" for specifics.) Relates to pharmacists and pharmacies, provides for the substitution of a biological product with an interchangeable biological product by a pharmacist, provides the pharmacist shall dispense the lowest retail priced interchangeable biological product which in in stock, requires the name of the interchangeable biological product shall appear on the prescription label, provides labeling exceptions, relates to maintaining a record of such transaction into interoperable electronic records. Yes

Yes

within 48 hours

(Communication)
No Yes

Yes

2 years

Yes

Hawaii

H 254
Signed 7/12/2016

Sponsor: Rep Evans

Allows for and regulates the dispensing of inter-changeable biological products. Requires pharmacists to inform consumers of interchangeable biological products from the Hawaii list when filling a prescription order and to communicate the product name and manufacturer to the practitioner after dispensing the product. Requires that less expensive ''interchangeable bioloical products be offered to the consumer.'' Repeals the Drug Product Selection Board.

Yes

Yes 

2 days
(Nofitication)
 

No

Patient consent only for anti-epileptic drugs

Yes

Yes. 
Same as generics

Yes

Idaho

H 483
Signed 3/24/2016

Sponsor: Health and Welfare Cmte.

Adds to existing law to provide that a pharmacist who dispenses an interchangeable biological product ''shall communicate to the prescriber the name and manufacturer of the drug within five business days following the dispensing of the biological product. Communication shall occur via an entry in an interoperable electronic medical records system, an electronic prescribing technology, a pharmacy benefit management system or a pharmacy record that can be accessed electronically by the prescriber.''

Yes

Yes

5 days

(Communication)

No

No

No

No

Illinois

S 455; signed 7/30/2015

Sponsor: Rep. J. Cullerton

(See Rx Database, keyword "Biologics" for specifics). Provides that a pharmacist may substitute an interchangeable biological product for a prescribed biological product only if all of the following conditions are met: (1) the U.S. FDA lists interchangeable with the prescribed biological product, (2) the prescribing physician does not designate orally, in writing, or electronically that substitution is prohibited and (3) the pharmacy informs the patient of the substitution. Within 5 business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer. The communication be by electronic record, a pharmacy benefit management system, or a pharmacy record.

Yes

Yes
5 days

Yes

Yes

Yes

No

Indiana

S 262; Ch. 96,  signed 3/31/2014

Sponsor: Sen. Herdsman (R )

Allows a pharmacist to substitute an interchangeable biosimilar product for a prescribed biosimilar product if the prescriber and patient are notified; and the prescribing practitioner has signed “May substitute” on the prescription. Requires the pharmacist to keep related records. Requires the Board of Pharmacy to maintain on its website a current list of all approved products that are interchangeable. Prescribed written or electronic prescriptions must comply with existing prescription form requirements.

Yes

Yes

Yes

(prior to dispensing)

Yes

Yes

Yes

Iowa

H 305

Signed 3/10/2017

Sponsor: Human Resources Cmte.

Creates a state process for pharmacists to substitute interchangeable biological products, requires notification to patients and within 5 days communicate with prescriber.  "If the cost of the prescription or any part of it will be paid by expenditure of public funds authorized under chapter 249A, the pharmacist shall exercise professional judgment by selecting a biological product that is an interchangeable biological product for the biological product prescribed for dispensing and sale."

Yes

Yes

5 days
(Communication)
 

Yes

"shall inform"

Yes

If prescriber specifically indicates that no drug product selection shall be made”

No

Yes

Kansas

HB 2055 of 2017 Mandates patient notification for pharmacist substitution of biologic drugs and also requires an electronic records entry to notify the prescriber, and a list of FDA approved biosimilars to be posted. No Yes
5 days (Communication)
Yes N/A

Yes

5 years

Yes
Kentucky S 134
Signed 4/11/2016
Sponsor: Sen. Alvarado (R)
(See Rx Database, keyword "Biologics" for specifics.)  Defines biological product and interchangeable biological product and to re-order other definitions, requires lower-priced biological products to be dispensed when appropriate unless notified otherwise and require labeling and notification of biological product substitutions, adds biological products to inspection requirements.       Yes

Yes

5 days (Communication)

Yes Yes

Yes

2 years

No

Louisiana

H 319

Signed 7/1/2015
Sponsor: Rep. Simon (R)

(See Rx Database, keyword "Biologics" for specifics). Provides for authorized interchangeable biological products and equivalent drug products, requires, following the dispensing of a biological product, the dispensing pharmacist to communicate, without any cause for action, to the prescriber the specific product provided to the patient, the name of the product and the manufacturer. Exception is made if the prescription is a refill or the prescription is indicated "dispense as written". Yes

Yes

5 days

Yes Yes No No
Maine S 432
Enacted July 4, 2018 without governor's signature

Requires Brand Manufacturers to sell an already-marketed drug to a developer of a generic version of that drug

Law ''ensures increased competition in the market for drugs and biological products." Amends the Maine Pharmacy Act to require that a drug distributed in this state must be made available for sale in this state to a person seeking to develop an application for the approval of the drug under the Federal Food, Drug, and Cosmetic Act or the licensing of a biological product under the federal Public Health Service Act; establishes disciplinary actions for noncompliance. Does not regulate dispensing of biologics or biosimilars to the public. (updated 7/20/2018)

N/A N/A N/A N/A N/A N/A

Maryland

SB 997
 as of 2017

Authorizes a pharmacist to substitute a biologic drug when applicable, to notify patients of the availability of a lower price option, and to post a list of FDA approved interchangeable drugs. Yes

Yes
5 days

(Communication)

Yes Yes No Yes

Massa-chusetts

H 3734;

Ch. 143 signed 6/23/2014

Sponsor: Rep. Cusack (D)

Provides that a pharmacist may substitute an interchangeable biological product for a trade or brand name biological product unless “the prescriber instructs otherwise in writing.” If a substitution is made, the prescriber must be notified in writing within a “reasonable time,” including via an electronic health record (EHR). Also, must notify the patient or patient's authorized representative of the substitution. Pharmacist, prescriber and administering practitioner must retain a record of substitutions for at least one year.  Authorizes the Department of Public Health to issue regulations and specify enforcement.      

Yes

Yes

incl. EHR

Yes

Yes

Yes

1 year

No

Michigan MI H 4472 of 2018, signed 2/28/2018. Sponsor: Rep. Bizon (R) Allows pharmacists to dispense designated interchangeable biological drugs and drug products, provides criteria for the dispensing of  interchangeable biological drugs and drug products. The pharmacist may, or when a purchaser requests a lower cost generically equivalent drug product or interchangeable biological drug product, the pharmacist shall dispense a lower cost but not higher cost generically equivalent drug product or interchangeable biological drug product if available in the pharmacy (Public Act No. 41) Yes Yes
5 days

Yes

"inform purchaser"

Yes

(Dispense as written or equivalent)

No Yes

Minnesota

HF 712 of 2017

 

 

Also see MN H 2749 (Step therapy use restriction only)

Yes

Yes
5 days (Communication)

Yes

Yes

(Dispense as written)

Yes

No

Missouri

S 875
signed 6/8/2016

Sponsor: Sen. Schaefer (R)

Creates a state process for pharmacists to substitute interchangeable biological products, requires notification to patients and within 5 days communicate with prescriber.  The pharmacist may, unless requested otherwise by the purchaser, select a less expensive generically equivalent or interchangeable biological product.

Yes

Yes
5 days

(Communication)

Yes

Yes

Yes
5 years

Yes

Montana

H 233

Signed 2/22/2017 as Ch. 42

Sponsor: Rep: Ehli

 

Establishes requirements for pharmacists to dispense FDA-approved interchangeable biological products. A pharmacist who receives a prescription for a specific biological product may select a less expensive interchangeable biological product.

Yes

Yes

5 days

(Communication)

No

Yes

Yes

2 years

No
Nebraska

LB 481
 of 2017

Updates laws to allow for substitution of FDA approved biologics. Yes

Yes

3 days (Communication)

Yes Yes No No

Nevada

AB 245

2017
Relates to pharmacy, requires a pharmacist or his or her designee to make certain entries any time a biological product is dispensed under certain circumstances, requires the dispensing of an interchangeable biological product in substitution for a prescribed biological product under certain circumstances, requires the State Board of Pharmacy to maintain certain lists of approved interchangeable biological products, published by the United States Food and Drug Administration, on its Internet website.  Yes

Yes

3 days (Communication)

No Yes N/A Yes
New Hampshire HB 1791, signed 2018
This enacted bill provides a pharmacist may substitute a biological product only if it has been licensed by the federal FDA as an interchangeable biological product. When a pharmacist dispenses an interchangeable biological product, the pharmacist shall inform the patient. The prescriber may block substitution by specifying "medically necessary."including giving instructions orally. Within 3 business days the dispensing pharmacist or designee shall  record the specific product provided to the patient, including the manufacturer. The communication shall be conveyed by making an entry that is electronically accessible to the prescriber.
Yes

Yes

3 days (Communication)

Yes Yes Yes No

New Jersey

A 2477; signed 11/9/2015; 
Sponsor Assm. Lampitt (D)

Establishes requirements for pharmacists to dispense FDA-approved interchangeable biological products. The pharmacist must communicate with prescriber of any substitution within five days. Includes required price disclosure to the consumer and the amount of savings if any, that would result if a substitution were made.

Yes

Yes

5 days

(Communication)

N/A/

Yes

Yes

same as Rx

Yes

New Mexico

H 260 of 2017
Signed 4/6/2017 as Ch. 48

Sponsor: Rep. Armstrong (D)  

A pharmacist may dispense any of the listed therapeutically equivalent drugs or interchangeable biological products that is lower in cost than the prescribed drug or biological product. A licensed practitioner can "prohibit drug or biological product selection by making an entry that is electronically accessible that includes the words 'no substitution' or 'no sub' on a prescription." Yes

Yes

5 days

(Communication)

Yes

"inform"

Yes No Yes
New York

S 4788 of 2017 Signed
10/23/2017

Sponsor: Richard N. Gottfried (D)

Substitution of Interchangeable Biological Products. Requires a pharmacist to substitute a less expensive biological product Yes

Yes

5 days

(Communication)

N/A Yes No Yes

North Carolina

H 195

Signed 
05/21/2015

Sponsor: Rep. Dollar (R)

Amends the Pharmacy Practice Act to allow for the substitution of an interchangeable biological product.

Yes

Yes

"reasonable time"
(Communication)

N/A

N/A

N/A

Yes

North Dakota

S 2190; Ch. 181; signed 6/26/2013

Sponsor: Sen. Dever (R)

 

Provides that a pharmacy may substitute a prescription biosimilar product for a prescribed product only if the biosimilar product has been determined by the FDA to be interchangeable; the prescribing practitioner does not specifically indicate that the brand is medically necessary and the pharmacist informs the prescriber and the patient of the substitution; the patient has a right to refuse the biosimilar product selected by the pharmacist and the individual chooses not to refuse.

Yes

Yes
within 24 hours

Yes

Yes

Yes

5 years

Yes

Ohio

HB 505

2016

Provides for the regulation of biological products and the substitution of interchangeable biological products when dispensed by pharmacists, requiring communication to prescriber. Yes

Yes

5 days

(Communication)

Yes Yes No No

Oregon

S 460; Ch. 342, signed 6/6/2013

Sponsor:  Sen. Monnes Anderson (D)

 

 

 

 

 

 

 

H 4105; signed Ch. 43, 3/14/2016
Health Care Cmt; Rep. Nosse (D)

 

Provides a pharmacy or pharmacist filling a prescription order for a biological product may not substitute a biosimilar product for the biological product unless certain conditions are met including the notification of the patient for whom the product is being prescribed and the practitioner or the practitioner's staff; requires the pharmacy and pharmacist to retain a record of the substitution; requires the Board of Pharmacy to post on its website a list of interchangeable biosimilar products. 

 

In 2016, H 4105 adds: ("shall inform the patient of the substitution prior to dispensing," also communicate within 5 days the specific biological product)

Yes

Yes
3 days

 

 

 

 

 

 

 

 

 

Yes
5 days

 

 

 

Yes

 

 

 

 

 

 

 

 

 

 

Yes,
prior to dispensing

Yes

Yes

3 years

Yes

Pennsylvania

S 514

Signed 7/20/2016

Amends the Generic Equivalent Drug Law (P.L.1163, No.259), provides for substitutions of FDA approved interchangeable biosimilar medicines if requirements are met, for posting requirements, for powers and duties of Department of Health and for immunity of pharmacists under certain circumstances.

Yes

Yes

Yes

Yes

Yes

Yes

Rhode Island

S 2755 &

H 7816

Signed 6/28/2016

Sponsors: Coyne (D); Serpa (D)

Adds biological products and interchangeable biological products to the medications pharmacies may dispense, regulates the procedures for dispensing and substitution of a less expensive biological product, authorizing use of an interoperable electronic medical records system and notification of interchangeability on a public state website.

Yes

Yes

5 days

(Notification)

Yes

"Shall inform"

Yes

Yes

Yes

South Carolina

H 3438 
Signed 4/28/2017 as Act 11 of 2017

Sponsor:  Reps. Henderson (R) 

An oral or written drug prescription "must provide an authorization from the practitioner as to whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted." Substitution may not occur unless the pharmacist advises the patient that the practitioner has authorized substitution and the patient consents.

Drug label must name substituted biologic unless barred by prescriber. Patient consent not required for Medicaid.

Yes Yes

Yes

Advise and consent

Yes No No

Tennessee

H 572 of 2015

S 984

Signed 5/4/2015.
Sponsor: Sen. Norris (R)

(See Rx Database, keyword "Biologics" for specifics).  Defines a biological product and an interchangeable biological product in the Tennessee Affordable Drug Act of 2005, authorizes a prescriber to substitute a prescribed biological product for an interchangeable biological product if certain requirements and restrictions are met.  Communication must occur within 48 hours, excluding weekends and holidays. Yes

Yes

5 days

Yes Yes

Yes

2 years

Yes

Texas

H 751
Signed 6/19/2015

Sponsor: Rep. Zerwas (R)

(See Rx Database, keyword "Biologics" for specifics). Relates to the prescription and pharmaceutical substitution of biological products. Adds biological products to the provisions of existing law which requires the notification of the patient and the prescribing practitioner when such there has been a substitution of interchangeable biological products for certain biological products, relates to patient options, requires maintaining a record for such product change, adds provisions regarding communication of such change, updates labeling requirements Yes

Yes

3 days
 

Yes Yes No Yes

Utah

S 78; Ch. 423; signed 4/26/2013

 

Sponsor: Sen. Stuart Adams (R)

 

2nd law, 

H 279

3/27/2015

Allows a pharmacist or pharmacy intern to substitute an interchangeable biosimilar product in the place of prescribed biological products if the FDA has determined that the biosimilar product is interchangeable; if the purchaser specifically requests or consents to the substitute; if the prescriber has not prohibited the substitute; also requires prescriber notification within three days (This provisions sunsets May 15, 2015). Also prohibits the substitution of a biosimilar product for the prescribed biological product without the prescriber's authorization; the interchangeable biosimilar product is approved to move through interstate commerce; the prescribing practitioner has not prohibited the substitution; and the substitution is not prohibited by law; regulates out-of-state pharmacies; relates to labeling and recordkeeping.

Yes

Yes

Yes

Yes

Yes

No

Vermont

S 92 of 2018, signed 5/30/2018

It requires prior authorization to refill a prescription with a drug or biological product different than the originally filled prescription; requires electronic notification from the pharmacy to the provider after dispensing biological products. Requires a pharmacist to select the lowest priced drug or interchangeable biological product.

Yes

Yes

5 days

(Communication)

 

Yes Yes No Yes

Virginia

H 1422; Ch. 412, signed 3/16/2013

Sponsor: Rep. O’Bannon (R)

Relates to dispensing of interchangeable biosimilar biological products. Permits pharmacists to dispense a biosimilar that has been licensed by the FDA as interchangeable with a prescribed biological product unless the prescriber indicates such substitution is not authorized or the patient insists on dispensing of the prescribed biological product. The pharmacist or his designee must inform the patient prior to dispensing the interchangeable biosimilar and must disclose the retail cost. The notification provisions sunset July 1, 2015.

Yes

Yes
5 days

Yes

prior

Yes
(MD or patient)

Yes 2 yrs.

No

S.1285, Ch. 544, signed 3/18/2013. Sponsor: Rep. Newman (R)

Washington

S 5935
Signed 2015

Sponsor: Sen. Parlette (R)
(See Rx Database, keyword "Biologics" for specifics). Provides an updated definition for interchangeable biological product and apply the generic substitution state prescription form requirement to select "dispense as written" to prevent substitution or "substitution permitted." Pharmacists must list the manufacturer of the drug dispensed electronically or manually in the patient's health records and retain a record like other prescription record retention. Also providing protection from any "greater liability" for selecting the interchangeable biological product, and protecting the prescribing practitioner as not liable for a pharmacist's act or omission in selecting an interchangeable biological product. Yes Yes
5 days
Yes Yes Yes Yes

Puerto Rico

H 1952;
Signed 2015
Sponsor: RepMendez Silva (PPD)

(See Rx Database, keyword "Biologics" for specifics). Amends Law 247 of 2004 known as the Pharmacy Act in order to create the definition of biosimilar products, establishes requirements for the dispensing of biosimilar products in Puerto Rico.

 

NCSL research; powered by StateNet and state websites

Mandatory Prescription Drug Substitution Laws

For a number of years before the discussion of biosimilars, at least 14 states and Puerto Rico have required the state-regulated pharmacist to substitute a generic version of the prescribed drug if all prescription requirements are met. These laws are not invalidated (for traditional non-biologic prescriptions) by biosimilar substitution measures enacted as of July 2016. These jurisdictions include:

Florida

Kansas

Kentucky

Massachusetts

Minnesota

Mississippi

Nevada

New Jersey

New York

Pennsylvania

Puerto Rico

Rhode Island

Washington

West Virginia  (Unless in pharmacist’s judgment; must be less expensive)

Source: NABP: 2014 Survey of Pharmacy Law, pp. 67 – 70.

Six states allow pharmacists to prescribe categories of medications independently

Colorado, Connecticut, Florida, Idaho, West Virginia, and Wyoming.

The role for Medicare programs.

Payment rates: Medicare pays for drugs administered in physicians’ offices or hospital outpatient departments (such as many biologics) based on the average sales price, net rebates, and other discounts reported to the government, plus a fixed percentage. Under this payment approach, providers would usually be penalized for choosing a lower-cost drug because the markup on a lower price is smaller in dollar terms. To prevent providers from facing this financial disincentive to prescribe lower-cost biosimilars, BPCIA requires Medicare payment for biosimilars to include a fixed percentage based on the more-expensive reference biologic. Subsequently, Medicare implemented a new payment policy for biosimilars that pay a blended average sales price for all biosimilars that share a common reference biologic drug, plus the fixed percentage of the more-expensive reference biologic, as required by BPCIA. Medicare’s payment approach could shift over time and it is not yet known whether private insurers are more aggressively incentivizing biosimilars through payment. [Rand study, 2017]

The role for Medicaid programs

On March 30, 2015, the Centers for Medicare and Medicaid Services released a guidance fact sheet that sets a framework by “issuing guidance to states on the classification of biosimilar biological products for rebate purposes and on strategies for states to use these products to reduce costs while improving access in terms of state Medicaid preferred drug lists.”[1]
      The CMS release emphasizes pricing and savings: “State Medicaid programs should view the launch of biosimilar biological products as a unique opportunity to achieve measurable cost savings and greater beneficiary access to expensive therapeutic treatments for chronic conditions. States and managed care organizations are encouraged to provide biologics that achieve desirable, cost-effective clinical outcomes for beneficiaries using the various drug utilization and cost management tools they have available (e.g., step therapy, prior authorization, preferred drug lists).”

[1] Biosimilars and the Medicaid Drug Rebate Program, HHS/CMS Manufacturer Release 92.  https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/MFR-Releases/mfr-rel-092.pdf

Other Recent News and Reports

Biologics Patent Expiration and Biosimilar Timeline (posted Jan. 2018)

More States Demand Notification to Use Biosimilar Drugs -  Read article by Stateline, March 30, 2015
[Excerpt]  Huge Savings Anticipated. Biologics are among the most expensive drugs. As Wiles noted, some cost thousands of dollars a month. In 2010, spending on biologics in the U.S. reached $67 billion, or nearly 30 percent of the overall prescription drug market, with a much steeper growth rate than conventional, drugs. Their imitations will cost far less. In Europe, where biosimilars already are available, they have been priced 15 percent to 30 percent less than their name brand versions. (In the U.S., generic versions of conventional, non-biological drugs can be up to 90 percent cheaper than name-brand versions.)

Federal Judge Allows Sale of Biosimilar Drug. From Bloomberg Business, "U.S. District Judge Richard Seeborg said in his ruling that the dispute between the drugmakers hinged on conflicting interpretations of the Biologics Price Competition and Innovation Act, the 2009 law that allows for fast-track approval of biosimilar drugs." Click here for links to articles on these topics from Kaiser Health News, March 2015.

Differing Views and Opinions

Not all health policy stakeholders agree on the role of state laws in regulating biological and biosimilar medications.  These are some additional views expressed during recent sessions deliberations. As always, NCSL takes no position for or against state legislation or laws.

Scott Gottlieb, FDA Commissioner, March 7, 2018: "Payors can also help us by doing more to educate clinicians about the safety and value of biosimilars, to encourage appropriate adoption. We’ll know that we’ve been successful when there’s a biosimilar market that can sustain multiple competing biosimilar and biologic options. For instance, in an FDA analysis of the market for white-blood cell stimulating biologics – which can help cancer patients fight off infections when they are taking chemotherapy – we’ve seen pricing relative to the incumbent biologic, Neupogen, decline by 34% after the approval of two competitors, with the competitors capturing nearly 50% of the market share, and saving payors $150 million annually." [Full text of statement.]  *NEW*

Institute for Patient Access: "Biological medications differ substantially from conventional drugs and are classified differently by the FDA; as a result, laws and regulations developed for conventional drugs cannot be applied to biologics. Under current state laws, pharmacists may substitute conventional generic drugs for name-brands without notifying the physician. However, with therapeutically interchangeable biologics, underlying differences in the medications or their manufacturing methods may cause adverse events in some patients or may lead individual patients to respond better to one biologic than another. Physicians must be able to determine exactly which biological medication was given so that they can optimize treatment for each patient. Moreover, in a transparent healthcare system, patients and physicians have a right to know exactly which medication patients receive."  Source: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2014/01/tppnp1.pdf (2014)

AHIP: "Remove barriers at the state level that restrict the use of biosimilars. While the Affordable Care Act authorized the FDA to develop an abbreviated licensure pathway for biosimilar drugs, it has yet to issue final standards that will determine when a biosimilar drugs is truly interchangeable with an already approved biologic. Ahead of these standards, some states have already adopted legislation that may restrict the availability of biosimilars before they even reach the market. These proposals will limit patient access to drugs that are not clinically different, yet cost substantially less than their brand-name counterparts." (America's Health Insurance Plans In "Specialty Drugs - Issues and Challenges", June 2014)

Pew Charitable Trusts: Biologic and Biosimilar DrugsHow Federal and State Policy Will Affect Their Use. 
Q: Are these state provisions necessary to protect patients?
A: Biosimilars deemed interchangeable by FDA are required by statute to be as safe and effective as an FDA -approved, reference biologic, including for patients switching between drugs. Therefore, state provisions are not necessarily needed to protect patients. FDA is likely to address the risks in switching to a biosimilar when it finalizes guidance on determining interchangeability. 

Q: What are the implications of state laws restricting substitution?
A: Although it is too early to know the impact of policies restricting biosimilar substitution, research indicates that limiting the substitution of conventional generics decreases uptake and increases drug prices. For example, one study found that requiring patient consent reduces rates of generic substitution by 25 percent. The same study concluded that state Medicaid programs could save over $100 million if patient consent requirements were eliminated for three top selling drugs
Full reportMarch 2016.

 

Biotechnology Industry Organization (BIO). "While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. (Indiana) SB 262 seek to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. BIO will continue to advocate for full transparency in the substitution process as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy. Bills such as this, that properly addresses the important aspect of physician communication, represent model legislation necessary in all 50 states to address this cutting-edge technology." (BIO statement in support of Indiana legislation, Feb. 26, 2014)

Governor Brown of California:  Bill 598 would effect two changes to our state's pharmacy law. First, it would allow interchangeable "biosimilar" drugs to be substituted for biologic drugs, once these interchangeable drugs are approved by the federal Food and Drug Administration (FDA). This is a policy I strongly support. Second, it requires pharmacists to send notifications back to prescribers about which drug was dispensed. This requirement, which on its face looks reasonable, is for some reason highly controversial. Doctors with whom I have spoken would welcome this information. CalPERS and other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics. The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold for "interchangeability." Given this fact, to require physician notification at this point strikes me as premature. For these reasons, I am returning SB 598 without my signature. (Governor's veto message, Oct. 8, 2013)

GPhA:  "Interchangeability: Interchangeability or substitution is the engine that drives generic competition. It is the reason why generic drugs have generated savings of $1.06 trillion over the past decade. The way that FDA deals with interchangeability will be directly responsible for the market dynamics generated by the biosimilar pathway." (Generic Pharmaceutical Association, "Biosimilars")
     Update: Compromise Agreement Announced -
“As state legislatures prepare for their 2015 sessions, I am pleased to announce that GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.
     The compromise legislation was put forward by several GPhA members and reflects our core principles: upholding the current pharmacy practice of automatic substitution; insisting on the science-based FDA determination of interchangeability; and treating all interchangeables and their corresponding brand biologics the same once an interchangeable is approved. The compromise language is a vast improvement over 2012 language that we strongly opposed, and which originally erected numerous barriers to the automatic substitution of interchangeable biologics…” (Statement by GPhA President and CEO, Dec. 9, 2014)

Biosimilars Council: "The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council applaud the enactment of legislation in five states to allow automatic substitution for Food and Drug Administration (FDA) approved interchangeable biologic products.  Bills in Colorado (SB 71), Georgia (SB 51), Tennessee (SB 984), Utah (HB 279) and Washington (SB 5935) reflect core principles embraced in language agreed upon by GPhA and a wide coalition of brand manufacturers, Express Scripts, and others. ... passing laws that create a competitive market for biosimilar products and provide patient access to affordable versions of these critical medicines,” (GPhA/Biosimilars Council release, May 13, 2015).  Additional information is available at www.biosimilarscouncil.org .

The Biosimilars Forum: The Biosimilars Forum will advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The Biosimilars Forum will provide evidence-based information to inform and support public policies that encourage access, awareness and adoption of biosimilars. (Forum website)

HRSA - U.S. Health Research and Services Administration (HRSA distributed the following advisory to providers on March 30, 2015)

On Friday, March 6, 2015, the U.S. Food and Drug Administration (FDA), using the authority provided in the Affordable Care Act, approved the first biosimilar product in the United States. Since the introduction of biosimilar products to the market could yield measurable cost savings and greater access to therapeutic treatment for chronic conditions, the following information may be relevant to the patients and populations you serve.

Biosimilars are a type of biological product that is licensed (approved) by the FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product) and have been shown to have no clinically meaningful differences from the reference product. Minor differences in clinically inactive components are allowed. But there must be no clinically meaningful differences between the biosimilar and the reference product it was compared to in terms of the safety, purity, and potency of the product.

Health care professionals can prescribe biosimilars just as they would prescribe other medications—by writing the proprietary name or nonproprietary name of the biosimilar on the prescription.

A biosimilar can be approved only for those indications and condition(s) of use previously approved for the reference product, but a biosimilar can be approved for fewer than all the indications and condition(s) of use approved for the reference product. Therefore, it is important for health care professionals to review the product labeling (prescribing information) to determine which conditions of use and routes of administration the biosimilar was approved for.

The FDA has developed a website about biosimilars specifically for providers. And, to learn more about biosimilars and Medicare Part B, please visit this website developed by the Centers for Medicare and Medicaid Services (CMS). You are encouraged to share both of these resources broadly.

Several other bills addressed use of biologics from different approaches. These measures are detailed in a separate off-line report, and include:

 

 “Right to Try Experimental Prescription Medicines State Laws and Legislation for 2014 -2018

State Laws Creating a "Right -to-Try" Drugs Unapproved by the FDA*

In 2013-14 there was an initial wave of state legislators seeking a new solution for how terminally ill patients can gain legal access to experimental drugs not yet approved by the U.S. Food and Drug Administration (FDA). By spring 2018 the number of similar laws had rapidly expanded, for a total of 40 state statutes.  

State Example:
Nebraska L 117, enacted 04/19/2018 as the Investigational Drug Use Act | Author: Hilkemann.
Summary: Adopts the Investigational Drug Use Act; provides eligibility requirements, provides that a manufacturer may provide an investigational drug, biological product, or device to an eligible patient without receiving compensation, prohibits an official, employee, or agent of this state from blocking an eligible patient's access to an investigational drug. Provides that this Act does not create a private cause of action against a manufacturer for any harm done resulting from the treatment.

Federal Law Enacted: This topic has significantly shifted in 2018, when the U.S. Congress caught up and passed a similar federal bill. On May 22, 2018 President Trump signed the congressionally approved federal Right to Try Law. 
♦ See Article "What is 'right to try' and will it help terminally ill patients?" posted by CBS News, 5/30/2018   
♦ Read: Congress OKs Letting Terminal Patients Try Unapproved Drugs , The Associated Press, 5/22/2018

Right to Try Experimental Prescription drugs- MAP

  • Within one year, 2014, five states (Arizona, Colorado, Louisiana, Michigan and Missouri) enacted first-in-the nation laws.
  • By 2015-2017, all 50 states had considered similar action.The results were laws signed in 33 additional states between January 2015 and December 2017. One state (Hawaii) enacted a bill in both chambers, but it was vetoed.
    In 2018 Nebraska became the latest enacted law
  • The total signed Right to Try state laws now stands at 40 states.

Read the NCSL Right to Try background report, describing the typical provisions the state legislative pro-con arguments, and the early phase of enacted laws, published March 2015.

Patient Impact: According to the original supporter and sponsor, The Goldwater Institute, "The results show that the impact of Right to Try isn’t merely theoretical."  They report - "Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State have received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist Dr. Ebrahim Delpassand continued their treatment through the Texas law." (Watch a video about Dr. Delpassand.)

Doubts and Cautions: "Despite these state gains and the policy's growing popularity among states, ethical questions remain about the tangible impact of a federal right to try law on Americans with terminal illnesses. Most notably, a growing body of evidence from policy analysts argues that the legislation would unfortunately accomplish very little change for most patients, and it could actually make it harder to get new drugs approved in the future." Analysis added spring 2018.

Expanded Access (Compassionate Use)- an FDA Update: In February 2015, the FDA announced a new, federally-approved "streamlined process" and a revised FDA webpage describing Expanded Access, sometimes called "Compassionate Use." It includes these features and facts. 

This policy focuses on the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). As the agency states online, "FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. Wherever possible, use of an investigational medical product by a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when patient enrollment in a clinical trial is not possible (e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials), patients may be able to receive the product, when appropriate, through expanded access."

General information about expanded access, with more detailed information (from the FDA website) on individual patient access to investigational drugs and biologics, referred to as a single patient investigational new drug (IND).

State Economic Development for Biosciences. 

2016: The Biotechnology Industry Organization (BIO) released a report, "The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life 2016," at the BIO International Convention. finds U.S. bioscience firms employ 1.66 million people, a figure that includes nearly 147,000 high-paying jobs created since 2001. The average annual wage for a U.S. bioscience worker reached $94,543 in 2014. These earnings are $43,000 greater, on average, than the overall U.S. private sector wage of $51,148.

2015: The Biotechnology Industry Organization (BIO) released “Bioscience Economic Development in the States: Legislation and Job Creation Best Practices  at the June 2015 BIO International Convention. “This report demonstrates the value of effective public policy in fostering the bioscience industry as an economic engine that provides high-wage, high-skilled jobs.” The Guide is the bioscience industry’s comprehensive analysis of state legislative and regulatory initiatives in support of economic development. 

Appendix:  Definitions related to Biologics

The following are some key definitions for policymakers to understand in considering regulations, with examples directly from state laws:

Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings. [from VA H1422 of 2013]

Biosimilar means a biological product that is highly similar to a specific reference biological product, notwithstanding minor differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product and the biological product that has been licensed as a biosimilar pursuant to 42 U. S. C. Section 262(k) in terms of safety, purity, and potency of the product. [from VA H1422 of 2013]

Interchangeable means a biosimilar that meets safety standards for determining interchangeability pursuant to 42 U. S. C. Section 262(k)(4).

[Federal law is excerpted below]

TITLE VII—IMPROVING ACCESS TO INNOVATIVE MEDICAL THERAPIES: Subtitle A—Biologics Price Competition and Innovation.

U. S. C. (United States Code) Section 262(k)(4)
Safety Standards For Determining Interchangeability.—Upon review of an application submitted under this subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to such application) is sufficient to show that—

‘‘(A) the biological product— ‘‘(i) is biosimilar to the reference product; and ‘‘(ii) can be expected to produce the same clinical result as the reference product in any given patient; and

‘‘(B) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
(Full text of FDA-related federal law: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ucm216146.pdf

Compiled by Richard Cauchi, NCSL Health Program, Denver

This edition is subject to additions and updated legislative status.

2017 Updates

  • "Should the FDA Relax Rules on Compassionate Access to New Drugs?," Wall St. Journal, April 11, 2017, featuring Working Group co-chair Alison Bateman-House and Goldwater CEO Darcy Olsen.
  • US Congress - Legislation, pending October 2017.
  • Working Group on Compassionate Use and Pre-Approval Access.  Testimony to US House Committee on Energy & Commerce, by Dr. Alison Bateman-House, assistant professor of medical ethics at NYU Langone Health."This group is composed of patient advocates, members of the pharmaceutical industry, individuals with clinical trial and compassionate use experience, bioethicists, lawyers, venture capitalists, and individuals with experience at the FDA and the Reagan-Udall Foundation for the FDA. The Working Group was formed before the Right to Try movement began, and there has been no litmus test of any sort, on Right to Try or any other topic, that members had to pass. And yet, every member of the group opposes Right to Try on ethical, legal, and pragmatic grounds." [Read statement; Oct. 3, 2017]
  •  Goldwater Institute - Testimony to US House Committee on Energy & Commerce by Ms. Naomi Lopez-Bauman, Director of Healthcare Policy.
    " We began our work on Right to Try about five years ago. Doctors and patients approached the Institute because dying patients were not getting access to innovative treatments while the wealthy and well-connected could seek innovative treatment overseas, leaving most others behind with few options.... Something is desperately wrong when terminal patients who are out of options are required to stand in line for permission to seek an investigational treatment that their doctor is recommending and that a manufacturer is willing to make available. Right to Try is about the terminal patients who don't fit into a control group, who can’t afford to travel or move to another country, and who simply want permission to seek the same treatments that other patients — sometimes in the same medical facility — are already receiving...  [Read statement; Oct. 3, 2017]
  • FDA Resources on Expanded Access (Updated 6/2016)
  • Investigational New Drugs: FDA Has Taken Steps to Improve the Expanded Access Program but Should Further Clarify How Adverse Events Data Are Used.” by U.S. Government Accountability Office., July 2017. Retrieved from: https://www.gao.gov/assets/690/685729.pdf 
  • How Do We Protect Patients From False Promises In Right-To-Try Laws?  Legislation before Congress seeks to grant all terminally ill patients the “Right to Try” experimental therapies once approved alternatives have failed. In its current form, however, Right to Try may be more likely to hurt patients rather than help them. August, 2017, Health Affairs.
  • "Costly Cures:" Hep C Sets the Bar -"Effective but very expensive drugs are forcing state Medicaid directors to make some tough decisions. NCSL State Legislatures Magazine, February 2017. by Michael Booth 

State Laws Creating a "Right -to-Try" Drugs Unapproved by the FDA*

Latest News: Between 2013 and May 2018, all 50 states considered bills, with recent laws now in at least 40 states. [Chronology listed below]

On May 22, 2018 the U.S. Congress caught up and passed a similar federal bill. ReadCongress OKs Letting Terminal Patients Try Unapproved Drugs , The Associated Press, 5/22/2018

U.S. Map of state laws allowing "Right-To-Try" not yet approved prescription Drugs (= 40 states as of May 2018)In 2013-14 there was an initial wave of state legislators seeking a new solution for how terminally ill patients can gain legal access to experimental drugs not yet approved by the U.S. Food and Drug Administration (FDA)- the result was five new laws. . By the end of December 2017 the number of similar laws had rapidly expanded, to 38 states. Two of the most recent additional states to enact "Right to Try" are Nebraska, L 117 and Wisconsin,  S 84.

State Example:
Nebraska L 117, enacted 04/19/2018
 as the Investigational Drug Use Act | Author: Hilkemann

Summary: Adopts the Investigational Drug Use Act; provides eligibility requirements, provides that a manufacturer may provide an investigational drug, biological product, or device to an eligible patient without receiving compensation, prohibits an official, employee, or agent of this state from blocking an eligible patient's access to an investigational drug. Provides that this Act does not create a private cause of action against a manufacturer for any harm done resulting from the treatment.

This issue is not directly about biologics and biosimilars, but it has attracted a growing share of attention.

Revises provisions relating to biological drugs and products; provides that a biological product shall be labeled in a specified manner; provides that the term drug product does not include a biological product.
Witkos (R) , Tercyak P (D)