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Raft of Comments on FDA Biosimilar Draft Guidances Draw Attention to Protein Definition, Interchangeability and Naming

Jul 25th, 2012

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The definition of “protein,” the requirement for a “higher standard” for interchangeability, and the use of international nonproprietary names (INNs) for biosimilars were issues drawing particular attention from industry in commenting on FDA’s biosimilar draft guidances.

In mid-February, FDA released its much-anticipated draft guidance documents on the scientific and quality considerations for registering biosimilar products through the abbreviated licensure pathway established by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Accompanying the two draft guidances was a substantive 15-page Q&A document on BPCI Act implementation (IPQ “The News in Depth” February 13, 2012). The 60 day comment period on each of the three documents ended in mid-April.

The guidance release opened up a new chapter in the dialogue with industry on the future shape of biosimilar regulation in the US, and the documents drew extensive comment reflective of their significance to the biotech community.

Entered into the FDA quality guideline docket were about 400 pages of comments.  The 42 respondents either focused specifically on that guidance or addressed the three documents together.  The volume of comments and the lack of specificity in many of them to particular passages in the guidances will make the review process a challenging one for FDA.

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