Formycon, Zydus Keytruda biosimilar FYB206 wins FDA review acceptance

FDA accepted a Biologics License Application for FYB206, a proposed Keytruda biosimilar developed by Formycon with Zydus. Review target is 12 months under BsUFA, implying an FDA decision could come in Q3 2027. Filing triggers a regulatory milestone payment to Formycon under its US-Canada licensing deal with Zydus. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Formycon AG published the original content used to generate this news brief via EQS News (Ref. ID: corporate_2414470_en) on October 13, 2026, and is solely responsible for the information contained therein. (C)