Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada

Core Insights - Formycon AG and Zydus Lifesciences Limited have entered into a strategic partnership for the exclusive licensing and supply of FYB206, a biosimilar of Keytruda, in the U.S. and Canada [1][2] - The partnership allows Formycon to focus on development and regulatory submissions while Zydus will handle commercialization [2][3] - FYB206 is nearing the end of its clinical development phase, with primary endpoint data expected in Q1 2026 [2][5] - Keytruda, the reference product, generated global sales of $29.5 billion in 2024, highlighting the significant market potential for FYB206 [4][5] Company Overview - Formycon AG is an independent developer of high-quality biosimilars, focusing on various therapeutic areas including oncology [6] - Zydus Lifesciences Limited is an innovation-led life-sciences company with a strong presence in pharmaceuticals and consumer wellness, employing 27,000 people globally [7] Financial Aspects - Formycon is set to receive mid-teens million euros in upfront and milestone payments in 2025, with additional payments linked to development and regulatory milestones expected to total a mid-double-digit million euro range [3][5] - Upon market launch, Formycon will receive a mid-double-digit share of the gross profits generated from FYB206 in the U.S. and Canada [3][5] Market Context - The biosimilars market is projected to grow significantly, with current global sales around $21 billion and expectations to exceed $74 billion by 2030 [8] - The introduction of biosimilars is expected to enhance patient access to biopharmaceutical therapies while reducing healthcare costs [8]