1. Formycon partners with Zydus for biosimilar Keytruda® in the U.S. 2. Zydus plans to leverage 225 FDA-approved products for FYB206 launch. 3. Primary endpoint data for FYB206 expected in Q1 2026. 4. Keytruda® saw $29.5 billion sales in 2024, indicating high market potential. 5. Biosimilars market projected to reach over $74 billion by 2030.
FAQ
Why Bullish?
The partnership for Keytruda's biosimilar signals market competition, likely impacting MRK's sales.
How important is it?
This collaboration could provide direct competition and decrease MRK's market share in oncology.
Why Long Term?
Clinical data in 2026 will reflect long-term competitive impact on Merck's revenue.
Formycon and Zydus Announce Strategic Licensing Partnership for FYB206
Formycon AG (FSE: FYB) has joined forces with Zydus Lifesciences Limited in a significant agreement to license and supply FYB206, a biosimilar of Keytruda® (Pembrolizumab), for the U.S. and Canadian markets. This announcement was made on December 9, 2025, as both companies aim to leverage their strengths in the oncology sector to provide affordable cancer treatment options to patients.
Details of the Agreement
The partnership outlines a comprehensive arrangement where Formycon will complete the clinical development of FYB206, prepare the necessary regulatory submissions, and supply the product. In contrast, Zydus will handle commercialization efforts across the United States and Canada.
- Clinical development for FYB206 is nearing completion, with primary endpoint data expected in early 2026.
- Formycon will also submit a biologics license application (BLA) to the U.S. FDA upon finalization of the data package.
Financial Implications and Future Milestones
Upon the signing of the agreement, Formycon is set to receive mid-teens-million-euro upfront payments, along with milestone payments anticipated in 2025. Additional financial considerations include:
- Mid-double-digit-million-euro range linked to specific development and regulatory milestones.
- A share of mid-double-digit gross profits from FYB206 once it launches in the specified territories.
Background on Keytruda® and Market Potential
Keytruda®, a leading treatment in oncology, generated global sales of approximately US$ 29.5 billion in 2024, highlighting its significant market presence. As a biosimilar to Keytruda®, FYB206 is positioned to meet the increasing demand for effective cancer therapies.
Statements from Company Leadership
Dr. Stefan Glombitza, CEO of Formycon, emphasized the importance of this collaboration, stating: "Partnering with Zydus for the U.S. and Canada marks an important milestone for us. Zydus has a strong commercial footprint in the U.S., generating nearly half of its global revenue." This underscores confidence in Formycon’s ability to develop complex biosimilar medicines in highly regulated markets.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, noted: "This venture marks Zydus' entry into the North American biosimilar market, debuting with an immunotherapy product." This collaboration highlights Zydus' commitment to expanding access to affordable oncology care.
About Formycon and Zydus Lifesciences
Formycon AG is a prominent developer of high-quality biosimilars, focusing on critical areas such as immuno-oncology. The company aims to provide patients with access to effective and affordable medicines. Zydus Lifesciences Limited operates as an innovation-driven life sciences company, holding a strong position across a range of therapeutic areas and aspiring to enhance healthcare solutions globally.