India, Oct. 13 -- Zydus Lifesciences Ltd and Formycon AG announced that the US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda (pembrolizumab), for review. According to the companies, this is the first publicly announced acceptance of a Keytruda biosimilar application by the USFDA.
The BLA was submitted in Q3 2026, with a regulatory decision potentially expected in Q3 2027, based on the USFDA's targeted review timeline. The regulatory dossier has also been submitted to Health Canada.
Pembrolizumab is an immune checkpoint inhibitor used to treat several types of cancer. Worldwide sales of Keytruda, including its subcutaneous formulation Keytruda Qlex, r...