Policy & Issues

Biosimilars, like all biologics, are highly complex and represent a new class of medicine.  As such, a new policy framework to govern their approval and use must be established. This framework must be based on science and designed to promote patient benefit and safety.

BPC encourages the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services to finalize several biosimilar policies or refine existing final guidances. BPC believes that policies should encourage the development of biosimilars while protecting patient safety and satisfying the prescribers’ need for transparency when it comes to clinical data.

Key issues include naming, interchangeability, indication extrapolation, labeling reimbursement coding, and non-medical switching.


BPC applauds FDA for recognizing in its final guidance that each biological product needs a distinguishable non-proprietary name, including previously approved originator drugs. Distinguishable names for biological products foster pharmacovigilance through a detailed ability to track adverse events, a necessary step to preserve patient safety. FDA’s final guidance states that all biological products will bear a nonproprietary name that is a combination of a core name and a four-letter suffix, devoid of meaning. However, as BPC has voiced previously, biologics prescribers tell us that the suffix should be memorable, which cannot be easily accomplished when it is meaningless. We remain concerned that randomized four-letter codes may complicate the achievement of FDA’s goal to facilitate pharmacovigilance and prevent inadvertent substitution. In addition, interchangeable biosimilars should be assigned distinguishable names. Additional perspective on this issue provided in our related material.


BPC believes that biosimilar product labeling should contain all needed data for physicians to make appropriate prescribing decisions for their patients. The label is a critical tool for physicians to both make prescribing decisions and manage potential adverse events, including side effects and drug-to-drug interactions. As such, it is of the utmost importance that any drug label be complete and accurate. BPC advocates for final labeling guidance that requires more transparent labeling, including: a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market; a summary of the full clinical data submitted in support of biosimilar approval or a hyperlink to that date, and the FDA’s summary basis of approval, including identifying where biosimilar properties, structure and function differ from the reference product. Additional perspective on this issue provided in our related material.

Indication Extrapolation

BPC calls for case-by-case extrapolation determinations based on extensive analytic and clinical data. The FDA should proceed with caution when considering biosimilar application requests for indication extrapolation. Even though one biologic medicine has been proven effective in multiple disease states, it does not necessarily follow that a biosimilar product will have the same effect or efficacy. As such, BPC urges caution in approving indications for diseases for which no clinical data is produced. Additional perspective on this issue provided in our related material.


BPC applauds FDA for establishing interchangeability standards through their draft guidance. When this guidance is final, FDA’s policy will provide important scientific information for manufacturers to consider when seeking licensure for proposed interchangeable products. BPC believes data required to demonstrate biosimilarity should be robust and risk-based to build prescriber confidence in this new class of medicine. Such confidence is particularly important for interchangeable biosimilars as these products may be substituted for the reference product without intervention from the prescribing healthcare provider. BPC believes applicants seeking FDA approval of a biosimilar as interchangeable should submit an application and justification for all of the reference product’s conditions of use. Additional perspective on this issue provided in our related material.

Reimbursement Coding

BPC believes that unless a biosimilar is deemed by the FDA to be “interchangeable” with the reference biologic, the Centers for Medicare and Medicaid Services (CMS) should provide each biosimilar a unique J-code. Shared J-codes that force biosimilars into one blended rate cause confusion, potential misuse and can potentially have a negative impact on the future biosimilars marketplace. BPC urges CMS to rethink its payment policy for biosimilars and not take a generic approach for medicines that are, by definition, not generic. BPC supports a revised CMS policy requiring unique J-codes to support increased treatment options and innovation. Additional perspective on this issue provided in our related material.

Non-Medical Switching

BPC believes the physician-patient relationship must remain intact in order to provide the best care for patients. We are concerned that non-medical switching – forcing a stable patient to switch medicines for reasons such as cost rather than efficacy – undermines this relationship and could require treatment decisions to not be made based on medical need.

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