Formycon will complete the development of FYB206, prepare and file the regulatory dossier, and supply the biosimilar product. Zydus will manage its commercialisation.
FYB206 is nearing the end of clinical development, with primary endpoint outcomes anticipated in the first quarter of 2026.
Upon completion of the data package, Formycon will prepare the dossier for submission of the biologics licence application (BLA) to the US Food and Drug Administration (FDA).
Formycon will receive milestone and upfront payments in the range of €10m to €20m in 2025
Additional payments tied to development and regulatory milestones are expected to be part of this total.
On market launch of the product, Formycon will receive a mid–double-digit-share of gross profits in the region.
Pembrolizumab is a humanised monoclonal antibody used for treating various tumours.
Zydus Lifesciences managing director Dr Sharvil Patel 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.”