FDA Policy/General

FDA Hearing on Improving Biosimilar Marketplace

David McFarland

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Federal Register notice: FDA has announced a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketplace, including greater availability of biosimilar and interchangeable products. The agency is interested in feedback on the following topics, among others: 

  • 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.  

The hearing will be held at FDA’s White Oak Campus in Silver Spring, MD. To view the notice, click here.

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