On May 19, 2017, the period for submitting public comments on the FDA draft guidance on biosimilar interchangeability closed (for a discussion of the FDA draft guidance click here). The draft guidance was published on January 17, 2017 and the comment period for the notice was extended in response to several requests for an extension to allow interested persons additional time to submit comments. Fifty-two comments have been filed, including multiple biopharma industry organizations, several groups representing physicians, and numerous biopharma companies.
We have already reported on the comment submitted by the Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, and will post on some of the other public comments over the next couple weeks.
One such comment, from Vizient Inc., applauded the FDA’s approach and commitment to increasing awareness of biologic manufacturing and regulatory principles, but (1) requested clarification and additional detail from the FDA regarding how “current analytical methodologies may not detect or characterize all relevant structural and functional differences between the reference product and the proposed interchangeable product” and (2) encouraged the FDA to reconsider the exclusion of use of non-U.S. licensed reference product in interchangeability studies. Specifically, Vizient requested clarification on the “differences between the reference product and the proposed interchangeable product” because such differences are important for providers and patients. Vizient also requested that the FDA not exclude non-U.S. licensed reference products in interchangeability studies to minimize the need for conducting redundant clinical trials in determining biosimilarity.