AIPLA Comments on FDA Biosimilars Draft Guidances

While the Food and Drug Administration’s role in the scientific regulation of biologic drugs is generally outside this primary interest, implementation of the new abbreviated regulatory pathway for biosimilar products authorized under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) contains some aspects that impact intellectual property rights, including patents, trademarks, trade secrets, regulatory exclusivity, and IP litigation.

In view of this impact, AIPLA provides comments on those aspects of the Draft Guidances that more or less directly impact intellectual property rights, and therefore impact our membership. Specifically, AIPLA provides comments on three issues: (1) definition of “protein (except any chemically synthesized polypeptide)”; (2) molecules having a changed amino acid sequence compared with the reference product; and (3) publication of exclusivity expiration dates.