Podcast
Episode 106 — The FDA’s New Playbook: Biosimilars, National Priority Vouchers, and the Plausible Mechanism Pathway
December 15, 2025
The Latham team unpacks the FDA’s recent actions on the Commissioner’s National Priority Voucher program, the plausible mechanism pathway, and biosimilars — and what they could mean for development timelines, pricing, and market access.
Recent FDA actions are reshaping key aspects of drug and biologic development, including the Commissioner’s National Priority Voucher program, the “plausible mechanism” pathway for personalized therapies, and new draft guidance aimed at streamlining biosimilars and interchangeables. Join Washington, D.C. partner Nathan Beaton and counsel Monica Groat and Chad Jennings as they discuss how these moves differ from traditional policymaking, as well as the practical implications for pricing, manufacturing, M&A, and litigation risk in the healthcare and life sciences industry.
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