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Key Issues Vetted at FDA's Public Hearing on Biosimilars

  • 11.19.10
  • Sterne, Kessler, Goldstein & Fox P.L.L.C.

On November 2 and 3, 2010, the FDA held its first public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which established an abbreviated approval pathway for generic versions of biological products. According to the FDA, the purpose of the part 15 hearing was “to receive information and comments from a broad group of stakeholders, such as healthcare professionals, healthcare institutions, manufacturers of biomedical products, interested industry and professional associations, patient and patient associations, third party payers, current and prospective biological license application (BLA) and new drug application (NDA) holders, and the public, regarding implementation of the BPCI Act.” To that end, over 40 speakers representing a diverse array of biopharmaceutical companies, generic drug companies, trade groups, universities and patient advocacy groups presented prepared statements to a panel of FDA experts over the two days of hearings.

Although the FDA had solicited public comment on nine topics in particular, the majority of the comments from both the public and the FDA panel centered on fi ve key areas: 1) the type and amount of preclinical and clinical data necessary to establish biosimilarity, 2) the showing necessary to meet the heightened standard of interchangeability, 3) the naming conventions to be used for biosimilar products, 4) the extrapolation of data obtained in a clinical trial for one indication to support a biosimilar application for other approved indications of the reference product, and 5) the use of data from clinical trials conducted abroad to support a biosimilar application in the U.S. We have summarized below the key points for each of these issues that were raised at the hearings.

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