German pure-play biosimilar developer Formycon agrees licensing and supply deal for U.S. and Canada

Under the terms of the agreement, Formycon will complete development, regulatory filings, and manufacturing for FYB206, while Zydus will handle commercialization in the U.S. and Canada. The deal includes mid-teens-million-euro upfront and milestone payments to Formycon in 2025, additional development and regulatory milestones totaling a mid-double-digit-million-euro amount, and a mid-double-digit share of gross profits after launch.

FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon will prepare the dossier and submit the biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) in due course.

The core patent covering the active ingredient pembrolizumab (Keytruda) is expected to expire in 2028 in the U.S., which is when biosimilar competitors are most likely to be able to enter the market, according to a filing with the U.S. Securities and Exchange Commission (SEC).

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of $ 29.5 billion in 2024, Keytruda is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world, the statement said.