Formycon and Zydus Agreement for FYB206, a Biosimilar to Keytruda®
Wednesday, December 10, 2025
Formycon AG and Zydus Lifesciences have entered a strategic partnership for the exclusive licensing and supply of FYB206, a biosimilar version of pembrolizumab, for the U.S. and Canadian markets.
Pembrolizumab is a humanised monoclonal antibody used across multiple cancer indications. Keytruda®, its reference product, recorded global sales of US$29.5 billion in 2024, reflecting strong demand and significant market potential in oncology.
Under the agreement, Formycon will complete the development of FYB206, prepare the regulatory dossier, file the application, and handle product supply. Zydus will oversee commercialisation in both countries. FYB206 is nearing the end of its clinical development, with primary endpoint data expected in the first quarter of 2026. Once the data package is completed, Formycon plans to submit a Biologics License Application to the U.S. FDA.
The companies noted that the partnership marks a significant step for both sides. Zydus has a strong commercial presence in the U.S., where it generates a large share of its global revenue and markets more than 225 FDA-approved products, including injectables and hospital medicines. This track record is expected to support the future launch of FYB206. Formycon highlighted its progress in developing complex biosimilars for highly regulated markets and sees this agreement as part of its broader strategy of working with strong regional partners.
Zydus stated that the collaboration represents its entry into the North American biosimilar market, beginning with an immunotherapy product.
The agreement also aligns with the company’s plan to expand manufacturing capabilities in the U.S. through a proposed acquisition of Agenus Inc.’s facilities in California.
Source: formycon.com
