Zydus Partners with Formycon to Launch Keytruda Biosimilar in the US and Canada

Zydus Lifesciences Limited and Formycon AG have entered into an exclusive partnership to license and supply FYB206, a biosimilar version of Keytruda® (Pembrolizumab), for the US and Canadian markets. The announcement was made on December 9, 2025.

Roles and Responsibilities

Under the agreement, Formycon will handle the development, regulatory approvals, manufacturing and supply of FYB206. Zydus Lifesciences Global FZE, a subsidiary in the UAE, will take charge of marketing and selling the product in the US and Canada.

The companies expect to soon file the Biologics License Application (BLA) with the US FDA. Their shared goal is to make immunotherapy more accessible and affordable for patients.

What Zydus Says About the Partnership

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, said the partnership marks Zydus’ entry into the North American biosimilar market, starting with a major immunotherapy drug. He added that this collaboration aligns with Zydus’ recent plan to acquire Agenus Inc.’s manufacturing facilities in California, which the company aims to integrate for future production. According to him, this partnership will help Zydus grow and offer more affordable cancer treatments.

Formycon’s Perspective

Formycon CEO Dr. Stefan Glombitza said FYB206 reflects the company’s advanced skills in developing biosimilars for strict regulatory markets. He emphasised that working with Zydus—known for its strong regulatory and commercial experience—will help bring this important treatment option to more patients. He added that the partnership supports both companies’ commitment to improving access to medicines.

About Zydus Lifesciences

Zydus Lifesciences is an innovation-driven life-sciences group with a strong presence in pharmaceuticals, consumer wellness and MedTech. The company has operations across the US, India and other global markets. As of September 30, 2025, the group employs about 27,000 people, including 1,500 scientists. Its mission is to develop high-quality healthcare solutions that improve lives.

Read more, Steamhouse India Files Updated Papers for ₹425 Crore IPO.

Zydus Lifesciences Share Price Movement

Zydus Lifesciences share price (NSE: ZYDUSWELL) closed at ₹920, down ₹4.60 (0.50%) on December 9, 2025. The stock opened at ₹924.60, touched a high of ₹927.25, and hit a low of ₹912.60 during the day. Zydus Lifesciences currently has a market cap of ₹92,57,000 crore and trades at a P/E ratio of 18.82. The stock’s 52-week high is ₹1,059.05, while the 52-week low stands at ₹795.00. It offers a 1.20% dividend yield, with a quarterly dividend amount of ₹2.76.

About Formycon

Formycon AG is a leading biosimilar developer based in Germany. It works on treatments in areas like ophthalmology, immunology and immuno-oncology. The company manages almost the entire development cycle—from technical development to regulatory approval. Formycon has launched two biosimilars already and has several others under development. It aims to expand patient access to effective and affordable biologic medicines.

Conclusion

This partnership between Zydus and Formycon marks a significant step in bringing an affordable Keytruda biosimilar to patients in the US and Canada. With combined expertise in biosimilar development, regulatory processes and commercialisation, the collaboration aims to expand access to life-saving cancer therapies while strengthening both companies’ presence in major global markets.

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