States Looking at Biosimilar Regulation

Sydney Abbott, JD
Policy Coordinator, Association of Community Cancer Centers

Biologics play a significant role in the treatment of a number of cancers, and some of the patents for these biologics are expiring in the coming years: enter biosimi­lars. When nonb­iologic medications come off patent, generic forms of the medication enter the market, greatly reducing patient cost. Because of their nature, however, biosimilars are just as their name suggests, biologically similar but not identical to the reference biologic. This creates room for potentially adverse reactions to patients and it will be vitally important that biosimilars are regulated properly in the coming years.

A number of states have taken up legislation to address this issue and create a framework for automatic biosimilar substitution at the pharmacy. However, legislative language varies across the states and has led to irregular adoption of laws. Only 5 states to date have passed such regulation—Florida, Oregon, North Dakota, Utah, and Virginia; legislation in Illinois is currently pending. Eleven states rejected or let the legislation die at the end of the state session, including Arizona, Arkansas, Califor­nia, Colorado, Delaware, Indiana, Maryland, Mississippi, Pennsylvania, Texas, and Washington.

Although legislative language varies across the states, all legislation introduced thus far has the same core components:

1 Substitution should occur only when the US Food and Drug Administration (FDA) has designated a biologic product as interchangeable. There is a difference between biosimilar (or interchangeable) and generic drugs. Most prescription drugs are made through chemical processes that can be replicated exactly in generic form.

However, biologic products are made from living cells and therefore cannot be identically recreated. The FDA defines a biosimilar product as a “biological product that is highly similar to an already approved biological product notwithstanding minor differences in clinically inactive components, and for which there are no meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity and potency.”1

2 The prescribing physician must be able to prevent substitution. It is first and foremost important to preserve the physician–patient relationship and the decision-making authority that accompanies it. Therefore, it is critical that the prescriber has the opportunity to indicate directly on the prescription that substitution is prohibited.

3 The prescribing physician must be notified of the substitution. State legislation varies on the length of time the pharmacy has to notify the prescriber that an automatic substitution has been made. Bills range from 1 day to 5 days to a “reasonable time.” The Association of Community Cancer Centers (ACCC) supports notification within 72 hours, because the primary question with biosimilars remains patient safety. If the patient has an adverse reaction, the prescriber needs to know if a biosimilar was substituted for the prescribed biologic.

4 The patient, or patient’s authorized representative, should at a minimum be notified at the time of the substitution. Because biosimilars are not identical to biologics, patients must be made aware when they are not receiving exactly what was prescribed.

5 The pharmacist should keep records of the substitution for at least 5 years. This is another area that varies from state to state. Some bills require recordkeeping at the pharmacy for as little as 1 year, although 1 state requires pharmacy recordkeeping up to 10 years. The ACCC believes that pharmacies should keep a record of biosimilar substitution for a minimum of 5 years.

States will have to address this issue at some point, and it is likely 2014 will bring additional legislation regarding biosimilars. The ACCC will continue to support responsible regulation that includes protection of physician decision-making power and prescriber notification within 72 hours.

Reference
1. Sherman ER. Biosimilar biological products. FDA Biosimilar Guidance Webinar. February 12, 2012. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Approval Applications/TherapeuticBiologicApplications/Bio similars/ucm292463.pdf. Accessed January 27, 2014.

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