FDA accepts BLA for Formycon and Zydus Keytruda biosimilar

Formycon AG and Zydus Lifesciences have announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for FYB206 for review. FYB206 is a biosimilar candidate for the blockbuster drug Keytruda (pembrolizumab). According to the companies, this marks the first publicly announced acceptance of a BLA for a Keytruda biosimilar by the FDA.

The development program for FYB206 was conducted without a comparative Phase III efficacy study, following an agreement with the FDA in early 2025. This approach is intended to reduce development costs and accelerate the regulatory timeline. A final decision from the FDA is expected in the third quarter of 2027.

As a result of reaching this regulatory milestone, Formycon is entitled to a contractually agreed milestone payment from Zydus. Zydus holds exclusive marketing rights for the United States and Canada. A parallel application has also been submitted to Health Canada.