Zydus Lifesciences Global FZE, a subsidiary of Zydus, has entered into an agreement with Bioeq for the US commercialisation of Vascular Endothelial Growth Factor (VEGF) inhibitor Nufymco, an interchangeable biosimilar of Lucentis (Ranibizumab). This move follows the US Food and Drug Administration’s (FDA) approval of the Biologics License Application for Nufymco, expanding Zydus’ biosimilar portfolio in the US. Under the terms of the partnership, Bioeq will handle the development, manufacturing, registr ...

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]