Wedoany.com Report-Dec.14, Formycon AG and Zydus Lifesciences Limited have signed an exclusive licensing and supply agreement for FYB206, a proposed biosimilar to Keytruda® (pembrolizumab), covering the United States and Canada.

The therapy is nearing the end of clinical development, with primary endpoint outcomes anticipated in the first quarter of 2026.

Under the terms, Formycon will complete the ongoing clinical development of FYB206, compile the regulatory dossier, obtain marketing authorisation, and serve as the exclusive supplier of finished product. Zydus will be responsible for commercialisation in both markets.

The pivotal clinical study is in its final phase, with primary endpoint results expected in the first quarter of 2026. Following positive outcomes, Formycon will submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and the corresponding filing in Canada.

Formycon will receive upfront and near-term milestone payments totalling between €10 million and €20 million during 2025, plus additional development and regulatory milestones. Upon commercial launch, Formycon will earn a mid-double-digit percentage share of gross profits generated in the United States and Canada.

Pembrolizumab is a widely used humanised monoclonal antibody that targets the PD-1 pathway and is indicated for multiple oncology conditions.

Dr Sharvil Patel, Managing Director of Zydus Lifesciences, stated: "We are happy to collaborate with Formycon to develop and commercialise a biosimilar of Keytruda across US and Canada. This venture marks Zydus' entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus' recent proposed acquisition of Agenus' California, USA-based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organisational growth and deliver maximum value to patients through expanded access to affordable oncology care."

The partnership combines Formycon's established biosimilar development capabilities with Zydus' growing commercial presence in complex generics and specialty pharmaceuticals, positioning FYB206 as one of the first pembrolizumab biosimilars to target the North American market upon potential approval.