The U.S. Food and Drug Administration issued three draft guidance documents on February 9 that provide the first guidance for biosimilars—molecules that are “copies” of approved biological molecules (reference products). These documents offer the first glimpse of the approaches the FDA will take in the regulatory scheme for biosimilars.

The guidance documents are:

  • Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
    This provides recommendations on the scientific and technical information for the Chemistry, Manufacturing and Controls (CMC) section of a §351(k) application (Biosimilar application to the FDA), as well as an overview of the analytical factors to consider in an assessment of biosimilarity between a proposed product and a reference product.

The guidance documents provide latitude for the FDA to assess each proposed biosimilar on a case-by-case basis. The approach taken in the guidance documents is a “totality of evidence” approach in assessing whether a proposed biosimilar product is sufficiently “similar” to a reference product to warrant approval.

We recommend an initial review of the FAQ document for an introduction to the various issues involved with approval of proposed biosimilar products and the FDA’s response to them. For a deeper understanding of the likely issues involved with the development of proposed biosimilar products, a close reading of the second guidance document is needed.

The third guidance document will be of interest to those charged with CMC oversight or those who want an introduction to some of the technical issues involved with analysis of proposed biosimilar products.

The FDA is seeking public comment on each of the draft guidance documents. The notice in the Federal Register has not yet published, but once published, comments must be submitted within 60 days of publication.

The professionals in Ballard Spahr’s biotechnology and life sciences practices are following this rule-making closely and are available to work with you in the preparation of comments to the FDA. For a more in-depth discussion of these guidance documents, see our article, FDA Issues Highly Anticipated Biosimilar Draft Guidance.

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