Rosen Quoted on Interchangeability and Biosimilar Guidances

07 January 2015 BioWorld Today News

BioWorld Today

Partner David Rosen was quoted in a BioWorld Today article, “FDA: Interchangeability, Other Guidances for Biosimilars in the Works,” on January 7, 2015. The article discussed possible FDA guidance changes on interchangeability, biosimilar draft guidance on labeling, statistical approaches for analyzing similarities in data, and implications of Biologic Price Competition and Innovation Act (BPCIA).

Rosen was quoted saying, “Some of the differences of opinion may be one of the reasons the guidances are a long time in coming. For instance, concerns about the potential market impact of naming and interchangeability guidelines could subject the drafts to the interagency review process.”