Zydus Lifesciences announced that the pivotal Dahlia pharmacokinetic study (PK study) has successfully met its primary study objective. The randomized, double-blind, multi-centre clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda®. Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda® (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets.

"The positive clinical data for the FYB206 marks a key milestone in our collaboration with Formycon and reflects our shared commitment to expand access to affordable, life-saving oncology treatments." stated Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited. "FYB206 represents the absolute cornerstone of our strategic entry into the complex North American immuno-oncology market."

At the beginning of 2025, Formycon and the US Food and Drug Administration (FDA) had agreed on a streamlined clinical strategy that aims to sufficiently demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda®, based on comprehensive analytical data and data from the Dahlia PK study. Having achieved the primary study objective, Formycon is now focusing on completing all development activities to finalize the documents for regulatory approval. The company is working closely with the regulatory authorities to make FYB206 available as soon as possible after the exclusivity of the reference drug expires.

With the clinical data package effectively complete, this achievement clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA. This positions Zydus as a potential first wave filer and a new entrant in the North American immuno-oncology biosimilar market.