Today, the Food and Drug Administration (FDA) announced a public hearing to solicit input from the public on how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation that Congress intended to achieve under the BPCI Act. FDA hopes that a broad group of stakeholders, including patients, researchers, healthcare providers, manufacturers, interested industry, professional organizations, and the public will participate.
The FDA welcomes input from the public on how the Agency can enhance its efforts to increase access by patients to state-of-the-art, lifesaving treatment options by encouraging innovation and competition in the biological products marketplace. FDA is particularly interested in stakeholder input on how the Agency 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.
The public hearing will be held on Tuesday, September 4, 2018, from 9 a.m. to 5 p.m at the Food and Drug Administration’s White Oak Conference Center. For more information on how to register for the meeting or the live webcast please see the Federal Register Notice.
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