Ahmedabad: Zydus Lifesciences is stepping firmly into the high-stakes immuno-oncology space, moving closer to a US launch of its pembrolizumab biosimilar after reporting successful clinical development.
The randomized, double-blind, multi-centre Dahlia pharmacokinetic study demonstrated bioequivalence between FYB206 and the reference oncology drug Keytruda. Meeting the primary study objective confirms that the proposed biosimilar matches the original therapy in pharmacokinetic terms, a key regulatory requirement. With the clinical data package effectively complete, the company said this achievement paves the way for a near-term Biologics License Application filing with the USFDA.
Zydus has in-licensed FYB206 exclusively from Formycon AG for the United States and Canadian markets. At the beginning of 2025, Formycon and the US Food and Drug Administration agreed on a streamlined clinical strategy designed to demonstrate therapeutic comparability using analytical data and results from the Dahlia study. Formycon is now focused on wrapping up remaining development work and preparing regulatory dossiers in coordination with authorities.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, described the positive clinical data as a key milestone in the company’s collaboration with Formycon. He indicated that FYB206 forms the cornerstone of Zydus’ planned entry into the complex North American immuno-oncology market and reflects a broader push to expand access to affordable, life-saving oncology treatments.
Pembrolizumab is a humanized monoclonal antibody used across multiple tumor types. With global sales of US$ 31.6 billion in 2025, Keytruda ranks among the world’s best-selling drugs, underscoring the size of the oncology opportunity. By positioning itself as a potential first-wave filer once reference drug exclusivity expires, Zydus aims to secure an early foothold in this fast-growing segment. The announcement was submitted to stock exchanges on February 27, 2026 as part of a formal disclosure.
Disclaimer: This article is based solely on the company’s press release dated February 27, 2026, and does not include independent verification or additional reporting.
