ASBM Submits Comments to FDA on Biosimilars

On September 21st, 2018 ASBM submitted comments to FDA as a follow-up to September 4th Public Hearing “Facilitating Competition and Innovation in the Biological Products Marketplace”, at which three ASBM Chairs, and several Steering Committee members testified.

The purpose of the hearing and the request for comments, is to seek input on how the FDA can achieve the following goals:

  • Facilitate the efficient development of biosimilar and interchangeable products using state-of-the-art science;
  • Develop information resources, as well as scientific or regulatory tools, to streamline the development of biosimilar and interchangeable products;
  • Enhance the efficiency of FDA review of marketing applications for biosimilar and interchangeable products;
  • Provide additional scientific or regulatory clarity regarding FDA’s regulation of biological products, including FDA’s review and approval of marketing applications for biological products;
  • Increase healthcare provider, patient, and payor understanding of biological products, including biosimilar and interchangeable products; and
  • Support market competition by addressing attempts to game FDA requirements or otherwise delay market entry of competing biological products.

Read ASBM’s full comments here.