A major collaboration aims to expand access to immuno-oncology treatments as FYB206 moves toward FDA submission.
Mumbai, India, 10 December 2025 – Zydus Lifesciences has entered into an exclusive partnership with German biosimilar developer Formycon AG to license and supply FYB206, a proposed biosimilar to the cancer immunotherapy Keytruda (pembrolizumab), for the United States and Canadian markets. The agreement marks a significant expansion into North America’s fast-growing biosimilars sector.
Under the deal, Formycon will lead the development, regulatory filings, manufacturing, and global supply of FYB206. Zydus Lifesciences Global FZE, the company’s UAE-based subsidiary, will oversee commercialisation across the two markets. The companies confirmed that a Biologics License Application for the biosimilar is expected to be filed with the US Food and Drug Administration soon.
The timing aligns with increasing worldwide acceptance of pembrolizumab. In 2023, India’s regulatory authority approved Keytruda for treating triple-negative breast cancer and renal cell carcinoma in adults, making it the first immunotherapy in India approved for certain high-risk cases. Pembrolizumab works by blocking the PD-1 pathway, helping the immune system better detect and attack cancer cells.
Zydus managing director Sharvil Patel said the partnership represents the company’s strategic entry into the North American immuno-oncology biosimilars market. He added that the collaboration complements Zydus’ proposed acquisition of Agenus Inc.’s manufacturing facilities in California, which are expected to support future production needs.
Formycon chief executive Stefan Glombitza said the programme demonstrates Formycon’s expertise in developing biosimilars for regulated markets. He noted that Zydus’ strong commercial and regulatory network will help support access and market reach for FYB206 in the US and Canada.
Zydus Lifesciences, headquartered in India, employs about 27,000 people globally, including 1,500 research scientists. The company operates across key global markets and continues to strengthen its biopharmaceutical capabilities.
Formycon AG specialises in biosimilars for immunology, immuno-oncology, and ophthalmology. Its marketed products include biosimilars to ranibizumab and ustekinumab, while its aflibercept biosimilar has received approvals in the US, EU, and UK. Several other candidates are in the pipeline.
The Zydus Formycon collaboration reinforces the increasing global focus on improving access to advanced cancer therapies through high-quality biosimilars.
