FDA Issues Draft Guidelines for Biosimilars

February 2012

Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"). While the pharmaceutical industry has eagerly awaited the FDA's announcement of its views on the regulatory requirements for biosimilar approval, the agency has declined, for now, to provide the type of detailed description many have been seeking. Instead, the draft guidelines set forth general principles to be applied during the approval process and made clear that the regulatory requirements that biosimilar applicants will be required to meet will be highly product dependent. As a result, while these guidelines provide useful insights into the FDA's views on the approval of biosimilar applications, the full scope of the challenges associated with obtaining regulatory approval for biosimilars remains uncertain.

The FDA draft guidelines are composed of three "Guidance for Industry" documents:

  • "Quality Consideration in Demonstrating Biosimilarity to a Reference Protein Product" ("Quality Guidelines")
  • "Scientific Consideration in Demonstrating Biosimilarity to a Reference Product" ("Scientific Guidelines")
  • "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and
    Innovation Act of 2009" ("Biosimilars Q&A").

Although not legally binding, these guidelines provide a description of the FDA's most current thinking about the biosimilar approval process. The Quality Guidelines set forth the analytical requirements for biosimilar approval, while Scientific Guidelines describe the clinical trial requirements for biosimilar approval. The Biosimilars Q&A provides general principles the FDA intends to apply to the approval of biosimilar products. Public comments on the draft guidelines will be accepted for 60 days.

The draft guidelines are directed to the approval of biosimilar therapeutic protein products, although the FDA notes that the scientific principles set out in these guidelines may also be applicable to the approval of other biosimilar products. "Protein" is defined by the draft guidelines to include "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." However, a "chemically synthesized polypeptide" – which is not subject to the biosimilar guidelines – includes "any alpha amino acid polymer that is (a) made entirely by chemical synthesis, and (b) is less than 100 amino acids in size." As a result, whether the draft guidelines will apply to follow-on protein products between 41-99 amino acids will depend entirely upon whether or not they are chemically synthesized.

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