Zydus Lifesciences has achieved a major milestone with its proposed Pembrolizumab biosimilar, FYB206. A pivotal pharmacokinetic (PK) study demonstrated bioequivalence with the reference drug, Keytruda®. Zydus holds exclusive rights from Formycon AG for the US and Canadian markets. This positive outcome clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA, positioning Zydus as a potential first-wave filer in the competitive North American immuno-oncology market.
Key Clinical Success for Immuno-Oncology Pipeline
Zydus Lifesciences announced on February 27, 2026, the successful completion of its pivotal Dahlia pharmacokinetic (PK) study for FYB206, a proposed biosimilar to the blockbuster immuno-oncology therapy Keytruda® (pembrolizumab).
The study, which was randomized, double-blind, and multi-centric, successfully met its primary objective, demonstrating pharmacokinetic equivalence (bioequivalence) between FYB206 and the reference drug, Keytruda®.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated that the positive clinical data marks a key milestone in the collaboration with Formycon AG and reinforces the shared commitment to expand access to affordable, life-saving oncology treatments.
Strategic Market Positioning
Zydus has in-licensed FYB206 exclusively from Formycon AG for the U.S. and Canadian markets. Keytruda®, the reference drug, generated global sales of US$ 31.6 billion in 2025, underscoring the substantial market potential for this therapeutic class.
The clinical data package is now effectively complete, which clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA. This positions Zydus to potentially be a first-wave filer and a new entrant into the complex North American immuno-oncology biosimilar market.
Next Steps in Development
Formycon is now focusing on finalizing all development activities and preparing the necessary documents for regulatory approval. This aligns with a streamlined clinical strategy agreed upon with the US Food and Drug Administration (FDA) at the beginning of 2025, which relied on comprehensive analytical data alongside the Dahlia PK study results.
Zydus Lifesciences is working closely with regulatory authorities to ensure FYB206 becomes available as soon as possible after the exclusivity period of the reference drug expires.
Source: BSE
