Zydus and Formycon Collaborate for Biosimilar Keytruda in North America

Zydus Lifesciences and Formycon's New Collaboration

Zydus Lifesciences Limited, a leading innovation-driven life sciences company based in Ahmedabad, India, has made a significant move in the pharmaceutical industry by entering into an exclusive partnership with Formycon AG. This collaboration targets the licensing and supply of FYB206, a biosimilar of the well-known immunotherapy drug Keytruda® (Pembrolizumab), specifically for markets in the United States and Canada.

The Partnership Explained

The recent agreement allows Formycon AG to take responsibility for the development, registration, manufacturing, and supply of FYB206, while Zydus Lifesciences Global FZE, a subsidiary of Zydus, will handle the commercialization processes in the designated regions. This division of labor between the two companies not only aims to streamline the pathway to market but also enriches the overall value offered to patients who require access to effective cancer treatments.

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, expressed enthusiasm about this venture, marking it as Zydus' entry into the North American biosimilar marketplace. The focus on immunotherapy products underscores a pivotal shift towards making vital treatments, like FYB206, more accessible and affordable for patients in need. The pending submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) progresses this mission forward, indicating a swift approach to enhancing patient access to lifesaving therapies.

Goals of the Collaboration

This collaboration with Formycon aligns with Zydus’ strategic growth initiatives, including their recent proposed acquisition of Agenus Inc.'s manufacturing facilities located in California. By integrating these assets with their own capabilities, Zydus anticipates bolstering its presence in the complex sphere of biosimilars, which is poised to be a significant area for healthcare innovation.

The partnership promises to combine both companies' strengths, enhancing patient welfare and expanding treatment options for cancer patients across North America. Dr. Stefan Glombitza, CEO of Formycon, highlighted the importance of this venture, noting that their expertise in developing high-quality biosimilars will ensure that patients have access to effective therapy options while reinforcing the collaboration’s commitment to medicine accessibility.

Zydus and Formycon: A Look Into Their Operations

Zydus Lifesciences has a robust framework built upon significant investments in research and development, employing over 27,000 people worldwide as of late September 2025. The company’s dedication to life sciences spans pharmaceuticals, consumer wellness, and emerging MedTech innovations. Their mission revolves around providing quality healthcare solutions, aiming to transform patient lives through groundbreaking discoveries and effective treatment methods.

On the other hand, Formycon AG is recognized for its role as a dedicated developer of high-quality biosimilars, catering primarily to therapeutics in immunology and immuno-oncology. With several biosimilars already on the market, forming the backbone of their operations, Formycon continues to expand its pipeline of candidates to ensure comprehensive offerings in the treatment of various diseases.

This key collaboration arrives with the promising prospect of bringing more treatment options into the market, showcasing the global trend towards increased accessibility and affordability in healthcare, especially within the realms of oncology.

Conclusion

The strategic partnership between Zydus Lifesciences and Formycon not only marks a significant advancement in the biosimilar market but also takes crucial steps toward improving access to essential cancer treatments in North America. With ongoing development and regulatory steps underway, both companies remain focused on enhancing the landscape of oncology care, ultimately aiming to uplift the quality of life for patients battling cancer. This collaboration stands as an emblem of innovation in healthcare, showcasing how strategic partnerships can lead to meaningful advancements in treatment accessibility and affordability.