Formycon and Zydus Sign Exclusive Licensing and Supply Agreement for FYB206, a Biosimilar to Keytruda®, in the U.S. and Canada
Wednesday, December 10, 2025
Formycon AG and Zydus Lifesciences have entered into a strategic partnership covering the exclusive licensing and supply of FYB206, a biosimilar version of pembrolizumab (Keytruda®), for the U.S. and Canadian markets.
Under the agreement, Formycon will complete the development of FYB206, prepare the regulatory dossier and supply the product. Zydus will manage commercial activities across both markets. FYB206 is nearing the end of clinical development, with primary endpoint data expected in the first quarter of 2026. Once the data package is complete, Formycon plans to submit a biologics licence application (BLA) to the U.S. Food and Drug Administration.
Formycon highlighted that partnering with Zydus supports its strategy of working with strong regional partners to advance access to biosimilars in regulated markets. Zydus brings a significant 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-use medicines.
Zydus noted that this collaboration marks its entry into the North American biosimilars market, beginning with an immunotherapy product. The partnership also aligns with Zydus’ proposed acquisition of Agenus Inc.’s manufacturing facilities in California, which the company aims to integrate into future production plans. Both companies expect the collaboration to support growth and help widen access to more affordable oncology therapies.
Formycon will receive an upfront payment in the mid-teens-million-euro range, along with additional milestone payments linked to development and regulatory progress. These payments are expected to amount to a mid–double-digit-million-euro total. After launch, Formycon will earn a mid–double-digit share of gross profits generated in the licensed territories.
Pembrolizumab is a humanised monoclonal antibody used across a broad range of tumour types. With global sales of USD 29.5 billion in 2024, Keytruda® remains one of the world’s top-selling cancer medicines, reflecting high demand for immuno-oncology treatments.
Formycon develops biosimilars for key therapeutic areas, including ophthalmology, immunology and immuno-oncology. Two of its products are already on the market, and a third has been approved by major regulators. Zydus Lifesciences is an innovation-led global healthcare company with a strong presence in pharmaceuticals, consumer wellness and medical technology, supported by extensive R&D capabilities.
Biosimilars are follow-on versions of biopharmaceutical products whose market exclusivity has expired. They promote competition, increase patient access to biological therapies and reduce pressure on healthcare budgets. The global biosimilars market is expected to grow significantly in the coming years as more leading biologics lose patent protection.
Source: globenewswire.com
