Back 

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

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

Richard Cauchi 7/2/2014

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 human growth hormone, injectable treatments for arthritis and psoriasis, the Hepatitis B vaccine and stem cell therapy.

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.”  

In the past one and a half years at least 23 states have considered legislation establishing state standards for substitution of a “biosimilar” prescription product to replace an original biologic product. 

Key Features of State Legislation | 2013-2014

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

  • Any biological product under consideration for substitution must be certified and listed as approved for substitution by the U.S. Food and Drug Administration or FDA. (No products have gained such approval as biosimilars in the United States as of June 2014.)
  • 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.”
  • The prescriber must be notified of any allowable substitution made at a pharmacy. (This would allow a physician to assess and compare the patient experience.)
  • The individual patient must be notified that a substitute or switch has been made in some cases, state law requires patient consent before any such switch is made.
  • The pharmacist and the physician must retain records of substituted biologic medications.
  • The state must maintain a public list of permissible interchangeable products.

The State Legislation Tally | As of July 1, 2014)

  • Eight states have enacted statutes.
  • One state (California) passed a bill through both chambers; it was vetoed by the governor.
  • 14 states had bills filed which are pending or did not pass as of session adjournments.

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” legislation, proposing to allow use of experimental drugs prior to full FDA approval.
  • Economic incentive measures intended to expand Bio research and manufacturing within individual states.

 

 

                  State Legislation Related to Biologics and Biosimilar Substitution

United States map of State Legislation Related to Biologics and Biosimilar Substitution

 

 
2013-2014 State Laws and Legislation

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

Doctor | Prescriber Notification

Patient Notification

Prescriber’s “Brand Medically Necessary” Blocks Substitution

Pharmacy Records Must Be Retained

Posted List of Interchan­geables

ENACTED LAWS

Signed in 8 states

 

 

 

 

 

 

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

Yes

Yes

Yes 3 yrs.

 

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

Yes

Yes 2 yrs.

Yes

Indiana

S 262; Ch. 96,  signed 3/31/2014

 

Sponsor: Sen. Hershman (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

Yes

Yes

Yes

Massa-chusetts

H 3734

Passed House & Senate;  
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 yr.

 

North Dakota

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

 

Sponsor: Sen. Dever (R);

co-chair HHS Comm.

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. Requires records retention for five years and public posting of such products.

Yes

Yes
24 hrs.

Yes

Yes

Yes

5 yrs.

Yes

Oregon

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

 

Sponsor:  Sen. Monnes Anderson (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. Effective upon passage, June 6, 2013.

Yes

Yes
3 days

Yes

Yes

Yes

3 yrs.

Yes

Utah

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

 

Sponsor: Sen. Stuart Adams (R)

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

 

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.

 

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

 

PASSED LEGISLATURE; Not Yet Law    (1 state)

 

 

 

 

 

 

California

S 598 of 2013; Passed Senate & Assembly;

Vetoed, 10/12/2013

 

Sponsor: Sen. Hill (D)

Authorizes a pharmacist, in his or her discretion, to select a biosimilar when filing a prescription order for a prescribed biological product only if the product has federal approval and the prescriber does not personally indicate “no substitution.” Requires that the pharmacy notify the prescriber or enter into a patient record the dispensed product. Prohibits a biosimilar unless the cost is less. Requires patient notification and posting interchangeable biosimilar products on a state specified Web site. Provides a pharmacist protection from liability when prescribing a biosimilar in accordance with this act.

Yes

Yes
5 days

Yes

Yes

 

Yes

 

Legislation FILED, PENDING OR DID NOT PASS, 2013-2014

State

Bill#

Status

Summary Description

Arkansas

S 149

2013; Failed-adjourned

Would regulate the substitution of biosimilar biological products for certain prescribed products.

Arizona

S 1438

2013; Failed-adjourned

Would provide 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 indicate that the brand is necessary and the pharmacist informs the prescriber and the patient of the substitution. Requires records retention for seven years and public posting of interchangeable products.

California

A 1139

(See passed bill above)

2013-14; Failed-adjourned

Would authorize a pharmacist filling a prescription order for a biological product subject to the Federal Food, Drug, and Cosmetic Act, to select a biosimilar product, as defined by federal statute, provided that product is deemed by the federal Food and Drug Administration to be interchangeable with the prescribed product.

Colorado

H 1121

2013; Failed-adjourned

Concerns the ability of a pharmacist to substitute a biosimilar product for a prescribed biological product when certain conditions are satisfied

Florida

S 732

(See enacted law  H 365, above) 2013

Would authorize a pharmacist to substitute a biosimilar product for a prescribed product if certain requirements are met.

Georgia

S 370

2013-14; pending
(Held in Senate Health & Human Services Comm., 6/14)

Relates to pharmacists and pharmacies; would provide for substitutions of interchangeable biological products; specifying requirements and limitations.  Patient may block substitution by specifying original; Physician may specify brand “medically necessary.”

Illinois

S 1934

2013-14; pending

Would amend the Pharmacy Practice Act, providing that a pharmacist may substitute a prescription biosimilar product for a prescribed biological product under certain circumstances, and provides that the Board shall adopt rules for compliance with these provisions.

Maryland

S 781

2013; Failed-adjourned

Would authorize pharmacists to substitute biosimilar biological products for prescribed biological reference products only under specified circumstances, requires pharmacists or their designees to give specified notices and record specified information if the pharmacist substitutes an interchangeable biosimilar biological product for a prescribed biological reference product.

Massachusetts

H 1927
 

2013-14. (combined with enacted law H3724, above)

Would provide 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;” 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 Dept. of Public Health to issue regulations and specify enforcement.

S 2176

(See  enacted law H3724, above)

Michigan

H 5598

2014; pending in Comm. on Health Policy. (Filed 5/27/14)

Would provide that a pharmacist may substitute an interchangeable product, once they notify the purchaser if a drug is dispensed that is not the prescribed brand name drug product.  Requires the pharmacist to indicate both the brand name prescribed and the generic name or biosimilar name of the drug product dispensed, and list each name on the prescription label.

Mississippi

H 1268

2014; Failed-adjourned

Would authorize the substitution of interchangeable biological products for a prescribed product by a pharmacist under certain circumstances.

H 1387

2013; Failed-adjourned

Would authorize the substitution of interchangeable biological products for a prescribed product by a pharmacist under certain circumstances.

S 2085

2013; Failed-adjourned

Would provide for the substitution of interchangeable biological products for a prescribed product by a pharmacist

Nevada

SB 126

2013; Failed-adjourned
(No action by Senate Comm.)

Would authorize a pharmacist to dispense a therapeutically equivalent drug in place of a prescribed drug under certain circumstances if the pharmacist has obtained the consent of the prescribing practitioner and the person presenting the prescription.  Would apply to both traditional generic drugs and biosimilars; requiring advising the person “that he or she may refuse to accept the therapeutically equivalent drug that the pharmacist intends to dispense” and require a written record at the pharmacy. 

New Jersey

A 2477

2014 pending

(Assembly Health & Senior Services Comm.)

Would permit a pharmacist to substitute biosimilar biological product under certain circumstances.

S 1705

2014 pending

(In Senate Health Comm.)

Oregon

H 2705

See Enacted law S 460

2013; Failed-adjourned

(Held in committee)

Would restrict substitution of biosimilar product for prescribed biological product, would become operative on passage.

Pennsylvania

H 746

2013-14; pending

(House Health Comm.)

Would amend the state Generic Equivalent Drug Law, further provides for biosimilar substitutions, for posting requirements, for powers and duties of Department of Health and for immunity of pharmacists under certain circumstances.

S 405

2013-14; pending

(Senate Appropriations Comm.)

Texas

H 542

2013; Failed-adjourned

Would specify the conditions for prescription and pharmaceutical substitution of biological products.

S 190

Vermont

H 837

2013-14; pending

(Held in Human Services Comm., 6/14)

Relates to generic substitution for biological products. Using the same standard as generic substitution, would provide that a prescriber can prevent substitution by specifically stating “brand necessary” or equivalent; the pharmacist must select the lowest priced FDA-approved interchangeable biological product unless otherwise instructed by the prescriber, or if the purchaser agrees to pay “any additional cost.”

Washington

H 1528

2013-14;
Failed-adjourned

Concerns the prescription of biological products and interchangeable biosimilar products.

S 5469

H 2326

 

2014; Failed-adjourned

Concerns the prescription of biological products and interchangeable biosimilar products. Would add biosimilars to existing law on generic drugs, to provide that, “Every prescription shall contain an instruction on whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted in its place, unless substitution is permitted under a prior-consent authorization.” If a biosimilar is substituted, a pharmacist must inform prescribing practitioner and patient of the name and manufacturer of the biological product dispensed and retain a record. The state pharmacy quality commission must link its web site to the current list of all approved interchangeable biological products.

S 6091

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 mandatorily 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 by biosimilar substitution measures enacted as of June 2014. 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.
 

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 the current session deliberations. As always, NCSL takes no position for or against state legislation or laws.

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)

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. FDA guidance on the requirements to obtain an interchangeability designation is needed for full realization of the benefits of biosimilars." (Generic Pharmaceutical Association, "Biosimilars")

 

Appendix:  Definitions

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

© 2014 National Conference of State Legislatures   Print edition: 7/1/2014 – This edition is subject to additions and updated legislative status.

Share this: 
We are the nation's most respected bipartisan organization providing states support, ideas, connections and a strong voice on Capitol Hill.

NCSL Member Toolbox

Denver

7700 East First Place
Denver, CO 80230
Tel: 303-364-7700 | Fax: 303-364-7800

Washington

444 North Capitol Street, N.W., Suite 515
Washington, D.C. 20001
Tel: 202-624-5400 | Fax: 202-737-1069

Copyright 2014 by National Conference of State Legislatures