skip to Main Content

FDA Seeks Stakeholder Input on How to Enhance Biosimilars and Interchangeable Biologics Market

  • This page as PDF


Earlier this week, the Food & Drug Administration (FDA) released a Part 15 public hearing announcement and request for comment on how the FDA can facilitate greater availability while balancing competition and innovation for all biologics.
Please note: This is an archived post. Some of the information and data discussed in this article may be out of date. It is preserved here for historical reference but should not be used as the basis for business decisions. Please see our main Insights section for more recent posts.

This hearing, at which stakeholders will provide suggestions to the agency on opportunities to improve the biosimilar and interchangeable product market, is a part of the FDA’s broader mission to protect and promote public health by fostering greater competition. The agency is seeking presentations from interested entities on how to accomplish the following:

  1. Facilitate the development of biosimilar and interchangeable products using state-of-the-art science
  2. Develop information resources, as well as scientific or regulatory tools, to streamline the development of biosimilar and interchangeable products
  3. Enhance the efficiency of FDA marketing application review
  4. Provide additional scientific or regulatory clarity regarding FDA’s biological products regulation processes
  5. Increase healthcare provider, patient, and payer understanding of biological products, including biosimilars and interchangeable products
  6. Support market competition by addressing attempts to game FDA requirements or otherwise delay market entry of competing biologic products

The FDA is also seeking industry feedback on additional steps it can take to support a sustainable, competitive, and multisource biologic product market. They look to accomplish this by encouraging the development of more biosimilars more efficiently through regulatory clarity and better communications to consumers and healthcare providers, while taking steps to prevent regulatory gaming. Some of these comment opportunities include: enhancing patient access, boosting provider and pharmacist confidence and familiarity with these products, and reducing developmental costs related to sample sizes for the analytical studies of difficult-to-source reference products.

The FDA has also stated that many current guidance documents are being considered for updates, including the recently rescinded draft guidance, “Statistical Approaches to Evaluate Analytical Similarity.” Commissioner Gottlieb has also mentioned finalizing the draft guidance, “Considerations in Demonstrating Interchangeability with a Reference Product,” which was issued in January 2017.

The public hearing will be held on September 4, 2018, and electronic or written comments will be accepted until September 21. The hearing agenda will become available on August 30.

To learn more about how you can engage in this public hearing, connect with us.

From beginning to end, our team synergy
produces measurable results. Let's work together.

Sign up to receive more insights about Regulatory Strategy and FDA Policy
Please enter your email address to be notified when new Regulatory Strategy and FDA Policy insights are published.

Back To Top