FDA Accepts FYB206, a Proposed Keytruda® Biosimilar, for Review

Formycon AG and Zydus Lifesciences Limited have jointly announced that the U.S. Food and Drug Administration (FDA) has accepted for review their Biologics License Application (BLA) for FYB206. This proposed biosimilar to Keytruda® (pembrolizumab) is reportedly the first publicly announced FDA acceptance of an application for a Keytruda® biosimilar.