Zydus Lifesciences Completes Clinical Study for Pembrolizumab Biosimilar FYB206

Zydus Lifesciences has successfully completed the pivotal Dahlia pharmacokinetic study for FYB206, a pembrolizumab biosimilar to Keytruda, demonstrating bioequivalence in a randomized, double-blind, multi-centre trial. In-licensed from Formycon AG for the US and Canadian markets, FYB206's positive clinical data supports a near-term Biologics License Application filing with the USFDA. This milestone advances Zydus' strategic entry into the North American immuno-oncology market, aiming to expand access to affordable oncology treatments.