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. Disc