Zydus/Formycon Biosimilar Accepted for USFDA Review

Zydus Lifesciences and Formycon AG announced that the US Food and Drug Administration (USFDA) has accepted their Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda® (pembrolizumab). This marks the first publicly announced acceptance by the USFDA for a Keytruda® biosimilar. FYB206 was developed without a comparative Phase III efficacy trial, following a pathway agreed upon with the USFDA in early 2025. Zydus holds exclusive commercialization rights for the United States and Canada. The BLA was submitted in Q3 2026, with a decision expected in Q3 2027. The regulatory dossier has also been submitted to Health Canada. This development is significant for expanding access to affordable pembrolizumab therapy.