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FDA’s Long-Awaited Biosimilars Guidances—The Prologue to Biosimilars in the U.S. has been published

David M. Fox

David M. Fox,

Washington, D.C.

14 February 2012

The U.S. Food and Drug Administration released three draft Guidances on implementation of the Biologics Price Competition and Innovation Act of 2009. The Q&A, Scientific Considerations, and Quality Guidances cover the overall framework for biosimilar application requirements as envisioned by FDA. Notably, FDA has deferred guidance on how to establish interchangeability.

FDA emphasizes a “step-wise” approach for sponsors in their development plans for biosimilars and the Agency’s “totality of the evidence” approach to review of biosimilar applications. While there is little that is unexpected or unanticipated for those that have been following the public discourse, there are a number of things to note:

  • Potential flexibility on the choice of clinical endpoints to support a proposed biosimilar, including endpoints different from those used to support approval of the reference product.
  • Potential flexibility on use of data from non-U.S.-licensed products as part of the demonstration of biosimilarity.
  •  Important discussions on delivery devices that accompany biological products, on establishing the biosimilar has the same “strength” as the reference product, and on the possibility of post-market studies for biosimilars.
  • How biosimilars may be labeled to identify the corresponding reference product, indication(s), route of administration, and interchangeability (or lack thereof).
  • A discussion of what constitutes “publicly available” information regarding prior determinations that the reference product is safe, pure and potent, including how the FDA’s  “action package” for a Biologics License Application (BLA) product may be used.
  • Definitions of “protein” and “chemically synthesized polypeptide” that affect whether products are regulated under the Public Health Service Act or Food Drug and Cosmetic Act.

The draft Guidances will be open for comment and the process and deadlines for submitting comments – including the scheduling of any public meetings on the Guidances – will be published in the Federal Register. We note that FDA took roughly five years to finalize the regulations governing the 1984 Hatch-Waxman Act on generic drug products. How the agency will process the volumes of comments that are likely to follow the publication of these landmark draft guidance documents will be interesting and worthy of close attention.

David M. Fox

David M. Fox,

Washington, D.C.

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