13-Oct-2026 09:47:36
ZYDUS : USFDA ACCEPTS FYB206 KEYTRUDA BIOSIMILAR BLA FOR REVIEW
• USFDA accepted Biologics License Application for FYB206, a proposed biosimilar to Keytruda (pembrolizumab) • To the best of the companies' knowledge, first publicly announced USFDA acceptance of a filing for a Keytruda biosimilar • BLA submitted in third quarter of 2026; USFDA aims to complete review within 12 months, decision expected in third quarter of 2027 • FYB206 developed without a comparative Phase III efficacy trial under a pathway agreed with USFDA in early 2025 • Zydus holds exclusive commercialization rights for the United States and Canada; Formycon responsible for development, filing and supply • Regulatory milestone triggers a milestone payment from Zydus to Formycon; dossier also submitted to Health Canada
Zydus Lifesciences Limited
Open attachment