Zydus and Formycon ink licensing agreement for biosimilar in US, Canada

Zydus will commercialise FYB206 in North America, while Formycon will lead development, regulatory filings and supply, with a US FDA filing expected soon

Zydus Lifesciences and Germany-based Formycon AG have entered into an exclusive partnership for the licensing and supply of FYB206, a proposed biosimilar to Keytruda (pembrolizumab), for the US and Canadian markets.

 

Under the agreement, Formycon will handle development, regulatory submissions, manufacturing, and supply of the product. Zydus Lifesciences Global FZE, the company’s UAE-based subsidiary, will be responsible for commercialising the biosimilar in the two North American markets. The companies said the Biologics License Application (BLA) for FYB206 is expected to be submitted to the US Food and Drug Administration soon.

 

The collaboration comes at a time when pembrolizumab has seen broader regulatory acceptance globally. In 2023, MSD (known as Merck in the US and Canada) announced that India’s Drug Controller General (DCGI) had approved Keytruda for the treatment of triple-negative breast cancer and renal cell carcinoma in adults. The approval covers high-risk early-stage and metastatic triple-negative breast cancer in select patients with a high likelihood of recurrence, making it the first immunotherapy cleared in India for adjuvant treatment in certain cases of renal cell carcinoma and early-stage TNBC. Pembrolizumab works by blocking the PD-1 pathway used by some cancer cells to evade T-cells, thereby enabling the immune system to better identify and target cancer cells.

 

Zydus managing director Sharvil Patel said the partnership marks the company’s planned entry into the North American biosimilars segment through an immuno-oncology product. He added that the collaboration aligns with Zydus’ proposed acquisition of Agenus Inc.’s manufacturing facilities in California, which the company intends to integrate for future production.

 

Formycon chief executive officer Stefan Glombitza said the programme reflects the company’s capabilities in developing biosimilars for regulated markets and that Zydus’ regulatory and commercial network will support market access for FYB206 in the US and Canada.

 

Zydus Lifesciences is an India-headquartered pharmaceutical and life-sciences company with operations across the US, India and other international markets. As of September 30, 2025, the group employed around 27,000 people, including 1,500 R&D scientists.

 

Formycon AG develops biosimilars across immunology, immuno-oncology, ophthalmology, and other areas. The company has two biosimilars on the market, ranibizumab (FYB201) and ustekinumab (FYB202), while its aflibercept biosimilar (FYB203) has been approved by regulators in the US, EU and UK. Several additional candidates, including FYB208, are currently in development.

 

Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co Inc, USA.