Zydus Lifesciences receives USFDA inspection observations and biosimilar review acceptance

Zydus Lifesciences has announced that a recent US Food and Drug Administration (USFDA) inspection of its Moraiya manufacturing facility in Ahmedabad concluded with five observations. The inspection took place between October 5 and October 13, 2026. While the specific nature of the observations was not disclosed, the company stated it is committed to addressing them promptly to ensure compliance with regulatory standards.

In a separate regulatory development, Zydus Lifesciences and Formycon AG announced that the USFDA has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to the oncology drug Keytruda. This marks what the companies believe to be the first publicly announced acceptance of a Keytruda biosimilar application by the USFDA. The BLA was submitted in the third quarter of 2026, with a regulatory decision potentially expected by the third quarter of 2027. A regulatory dossier for FYB206 has also been submitted to Health Canada.