Zydus Lifesciences Completes Pivotal Study for Pembrolizumab Biosimilar FYB206
Zydus Lifesciences announced successful completion of the pivotal Dahlia pharmacokinetic study for FYB206, a pembrolizumab biosimilar in-licensed from Formycon AG for U.S. and Canadian markets. The study demonstrated bioequivalence to Keytruda, completing the clinical data package and clearing the pathway for near-term USFDA BLA filing in the immuno-oncology biosimilar market.
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Zydus Lifesciences has achieved a major milestone in biosimilar development by successfully completing the pivotal Dahlia pharmacokinetic study for FYB206, a pembrolizumab biosimilar that demonstrates bioequivalence to the reference product Keytruda.
Pivotal Study Success
The company announced that the randomized, double-blind, multi-centre clinical PK study successfully met its primary study objective, demonstrating pharmacokinetic equivalence of FYB206 with Keytruda. This achievement represents the completion of the clinical data package required for regulatory submission.
| Study Parameter: | Details |
|---|---|
| Study Name: | Dahlia Pharmacokinetic Study |
| Study Type: | Randomized, Double-blind, Multi-centre |
| Primary Objective: | Successfully Met |
| Outcome: | Bioequivalence Demonstrated |
| Reference Drug: | Keytruda (Pembrolizumab) |
Strategic Partnership and Market Access
Zydus has in-licensed FYB206 exclusively from Formycon AG for the U.S. and Canadian markets. The successful study completion positions the company as a potential first-wave filer in the North American immuno-oncology biosimilar market.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated: "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. FYB206 represents the absolute cornerstone of our strategic entry into the complex North American immuno-oncology market."
Regulatory Pathway and Market Potential
With the clinical data package effectively complete, this achievement clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA. At the beginning of 2025, Formycon and the FDA had agreed on a streamlined clinical strategy to demonstrate therapeutic comparability of FYB206 with Keytruda.
| Market Information: | Details |
|---|---|
| Global Keytruda Sales: | US$ 31.60 billion (2025) |
| Drug Classification: | Immune Checkpoint Inhibitor |
| Target Markets: | U.S. and Canada |
| Filing Status: | Near-term BLA Preparation |
Pembrolizumab is a humanized monoclonal antibody used to treat various tumors, and Keytruda is currently one of the world's best-selling drugs with global sales of US$ 31.60 billion in 2025, underscoring the substantial market potential.
Company Profile
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, with a global footprint across the United States, India and other international markets.
Source: None/Company/INE010B01027/e8f76a26-0258-44c9-aa02-2cf8b5cb45d6.pdf
Historical Stock Returns for Zydus Life Science
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -1.79% | +2.14% | +4.50% | -6.70% | +3.98% | +111.79% |
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