FDA’s First Interchangeable Biosimilar Exclusivity Decision — Prelude to a New Wave of FDA Litigation?

Lexology November 15, 2023
Loeb & Loeb LLP

FDA has released an 18-page internal decision memo which for the first time lays out the agency’s interpretation of how regulatory exclusivity rights operate for “Interchangeable Biosimilar” products. The memo addresses a specific dispute between Pfizer and Boehringer Ingelheim over First Interchangeable Exclusivity (“FIE”) rights for interchangeable biosimilar versions of Abbvie’s blockbuster biologic product Humira. This FDA decision harkens back to the heyday of legal disputes that arose under the Hatch-Waxman Amendments involving NCE exclusivity, 3-year exclusivity, and especially 180-day exclusivity disputes involving first-filer generic applicants. Given the complexity of the biosimilars law, the seemingly infinite variety of potential fact patterns that can arise, and the potentially huge financial stakes involved in FIE eligibility and expiration issues, this could mark...

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