It is the last day of the conference, and we have some highlights for you. In a keynote address, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research provided a State of the Biosimilars and Generics Program.

By the numbers she indicated that in Fiscal Year (FY) 2024 OGD:

  • Has approved and tentatively approved over 850 ANDAs including 70 first generics, and 88 complex generics. Note: We will need the final numbers to be published before we can break those 850 approvals.
  • Has held 77 pre-ANDA meeting requests for advice on the development of complex generic products.
  • Has issued more than 200 new and revised product-specific guidances (PSGs) describing the FDA’s current thinking and expectations, including:
    • 31 PSGs that provided a more efficient bioequivalence approach.
    • 20 PSGs for complex drug products.

In addition, she noted that FDA received over 100 ANDA suitability petitions in FY 2024 with 95% being acted upon in 6 months. This is a breath of fresh air for the industry because since 2015 the suitability petition review process at the FDA basically came to a standstill.

As far as the Biosimilar program goes, the FDA has approved 61 biosimilar applications since the program began. These applications represent approvals for 17 different reference products, and as of today, 41 of these products are being marketed. Why not all 61? Well, there are a number of products that are caught up in patent litigations or awaiting a patent settlement date to be able to come to market.

Dr. Corrigan-Curay in discussing an update to the 2024 Interchangeability Draft Guidance noted that, “to-date FDA has generally recommended switching studies in the past as part of the data package needed to demonstrate interchangeability of a biosimilar; however, of the 15 approved interchangeable biosimilars, 13 were approved without additional clinical (switching study) data.

Experience has shown that for the products approved as biosimilars to-date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product.”

This is consistent with the current Agency position also outlined by Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars, and discussed at the Fireside Chat held at the AAM meeting on Day 2 (see here).

We have been concerned about how the current biosimilar legislation meshes with the current Agency thinking on interchangeability. Dr. Corrigan-Curay addressed this issue by indicating that the FDA’s FY 2025 Legislative Proposal includes:

  • “Elimination of the Statutory Distinction Between the Approval Standard for Biosimilar and Interchangeable Biosimilar Products and Deem that Approved Biosimilars are Interchangeable:
    • Confusion/misunderstanding among patients and health care providers about S&E of biosimilars and whether they are less S&E than interchangeable biosimilars.
    • U.S. biosimilar program more consistent with current scientific understanding, global regulatory approach, incl. E.U.
    • Potential to increase uptake of biosimilars, competition, access, affordability.”

While her presentation included a lot more information, these brief highlights illustrate the benefit of attendance at these types of meetings.