Zydus Completes Pivotal Study for Keytruda Biosimilar, Prepares USFDA BLA Filing
Ahmedabad: Zydus Lifesciences Limited has successfully completed the pivotal clinical development of its pembrolizumab biosimilar FYB206 and is preparing for a near-term Biologics License Application (BLA) filing with the US Food and Drug Administration (USFDA), marking a significant milestone in its North American expansion strategy.
Announcing the development on February 27, 2026, the company stated that the randomized, double-blind, multi-centre Dahlia pharmacokinetic (PK) study met its primary objective by demonstrating pharmacokinetic equivalence (bioequivalence) of FYB206 with the reference oncology drug Keytruda® (pembrolizumab).
Zydus has exclusively in-licensed FYB206 from Formycon AG for the U.S. and Canadian markets. The positive clinical data from the pivotal study underline progress in establishing therapeutic comparability with the reference product and support regulatory advancement.
Commenting on the milestone, Dr Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, said that the positive clinical data mark a key step in the collaboration with Formycon and reflect the shared commitment to expanding access to affordable, life-saving oncology treatments. He described FYB206 as the cornerstone of the company’s strategic entry into the complex North American immuno-oncology market.
At the beginning of 2025, Formycon and the USFDA agreed on a streamlined clinical strategy aimed at sufficiently demonstrating therapeutic comparability of FYB206 with Keytruda®, based on comprehensive analytical data and findings from the Dahlia PK study. With the primary endpoint achieved, Formycon is now focused on completing remaining development activities and finalizing regulatory documentation, working closely with authorities to enable availability after expiry of the reference drug’s exclusivity.
With the clinical data package effectively complete, the company stated that it is positioned as a potential first-wave filer and new entrant in the North American immuno-oncology biosimilar segment.
Pembrolizumab is a humanized monoclonal antibody and immune checkpoint inhibitor used across multiple oncology indications. The reference product, Keytruda®, recorded global sales of US$ 31.6 billion in 2025, highlighting significant market demand and commercial potential.
