NUFYMCO BLA has been approved by the USFDA
Bioeq AG, a Swiss biopharmaceutical company, and Zydus Lifesciences Limited, an innovation-focused life sciences company with a global presence, have announced a strategic collaboration through Zydus Lifesciences Global FZE, their wholly owned subsidiary in the United Arab Emirates. The partnership will focus on the licensing, supply, and commercialization of Bioeq’s vascular endothelial growth factor inhibitor, NUFYMCO, an interchangeable biosimilar to Lucentis (Ranibizumab) for the U.S. market. The U.S. Food and Drug Administration approved the Biologics License Application for NUFYMCO on December 18, 2025, marking a significant milestone for both companies. This agreement further expands Zydus’ presence in the U.S. biosimilar market following its recent collaboration with Formycon AG for a biosimilar version of Keytruda (Pembrolizumab).
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According to the agreement, Bioeq will manage the development, manufacturing, regulatory approvals, and supply of the finished product while Zydus will lead the commercialization efforts for NUFYMCO in the U.S. market. Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, said they are pleased to partner with Bioeq to bring an interchangeable biosimilar to Lucentis to patients in the United States. He emphasized that the collaboration combines the strengths of both organizations to accelerate growth and provide greater access to affordable ophthalmology treatments.
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Dr. Thiemo Schreiber, Vice President of Commercial at Bioeq, expressed excitement over the FDA approval of NUFYMCO as an interchangeable biosimilar. He highlighted that this addition reinforces Bioeq’s expertise in developing complex biosimilar medicines for highly regulated markets. Dr. Schreiber added that the partnership with Zydus will leverage the company’s broad distribution network and strong sales and marketing capabilities across the U.S., helping to expand treatment options and improve patient access to high-quality, affordable therapies. Both executives underlined their commitment to innovation and enhancing healthcare accessibility through this collaboration.
This partnership demonstrates a shared focus on advancing the availability of cost-effective biosimilars in the United States while maintaining the highest standards of quality and regulatory compliance. By combining Bioeq’s development and manufacturing experience with Zydus’ commercial expertise, the two companies aim to maximize the impact of NUFYMCO on the ophthalmology market and support better healthcare outcomes for patients nationwide.
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