Zydus and Formycon announced USFDA acceptance of biologics license application for FYB206

Zydus Lifesciences and Formycon AG (Formycon), an independent developer of biosimilars, today jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda?1 (pembrolizumab).

To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of an application for a Keytruda? biosimilar.

The BLA was submitted in the third quarter of 2026. Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027. The regulatory dossier for FYB206 has also been submitted to Health Canada.