by Amanda Conschafter, blog editor
Five years after the federal government approved an abbreviated regulatory pathway for biosimilars, physicians and patients still lack clarity on a number of core issues. So explains a new policy brief from the Institute for Patient Access, which notes that regulators must resolve these issues—particularly if they hope to instill confidence and ensure widespread adoption of biosimilars.
In “Unresolved Policy Issues Impact Patient Access to Biosimilars,” authors David Charles, MD, and Mary Ann Chapman, PhD, cite four central policy issues that require further action by regulators. These include:
- Biosimilar naming. Regulators continue to debate whether biosimilars will have names that distinguish them from their biologic reference products. Last month the FDA issued draft guidancesuggesting a system of randomly-generated, four-consonant suffixes—“biological qualifiers”—to generate distinct names. The proposed system differs from the approach used in naming the first U.S. biosimilar, approved earlier this year.
- Prescribing information. Generic forms of synthetic medications typically assume the prescribing information of their brand-name reference product. But physicians and advocates argue that biosimilars should come with information specific to their own clinical studies and safety data. The FDA used the reference product’s prescribing information for the first U.S.-approved biosimilar; it’s unclear whether the agency will continue this approach.
- Indication extrapolation. Medications must undergo extensive testing to prove that they are safe and effective for a specific indication, or FDA-approved use. With indication extrapolation, a biosimilar may receive one or more of its reference product’s indications without being fully tested for the condition it’s approved to treat. (The FDA extrapolated indications for the first biosimilar it approved.) The approach raises concerns among some physicians and patient advocates because biologics and their biosimilar follow-ons can affect patients differently.
- Interchangeability and physician communication. Some manufacturers may apply to have the FDA approve their biosimilar as interchangeable with its brand-name reference biologic. The designation suggests that the biosimilar is as safe and effective as the reference product, based upon FDA criteria. States must determine whether physicians will receive notification if a dispensing pharmacist replaces the biologic they prescribed with an interchangeable biosimilar. Currently, 14 of the 16 states that have passed legislation on biosimilar substitution require physicians to be informed. Only 10 require patients to be informed.
For more information, read “Unresolved Policy Issues Impact Patient Access to Biosimilars,” or visit AfPA’s educational video library.
