NUFYMCO® BLA has been approved by the USFDA
AHMEDABAD, India and ZUG, Switzerland, Dec. 23, 2025 /CNW/ -- Bioeq AG ("Bioeq"), a Swiss biopharmaceutical company, and Zydus Lifesciences Limited ("Zydus"), an innovation-led life-sciences company with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Bioeq, for the licensing, supply and commercialization of Bioeq`s Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO®, an interchangeable biosimilar of Lucentis®1 (Ranibizumab) for the U.S. market. The Biologics License Application (BLA) for NUFYMCO® has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025. This transaction marks an expansion of Zydus'U.S. biosimilar business, following its recent partnership with Formycon AG for a biosimilar of Keytruda®2 (Pembrolizumab).
Under the terms of this agreement, Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will be responsible for the commercialisation of NUFYMCO® in the U.S. market.
Speaking on the development, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, said, "We are happy to collaborate with Bioeq to bring an interchangeable biosimilar to Lucentis® (Ranibizumab) in the US market. Through this partnership, we will leverage our combined expertise and resources to accelerate organisational growth while ensuring maximum value to patients through an expanded access to affordable ophthalmology care."
Dr. Thiemo Schreiber, Vice President Commercial at Bioeq, stated, "We are excited about the regulatory approval of "NUFYMCO® by USFDA as an interchangeable biosimilar of Lucentis® (Ranibizumab). This latest addition to our portfolio reflects Bioeq's advanced expertise in developing complex biosimilar medicines for highly regulated markets. Our partnership with Zydus will leverage its extensive distribution network and strong sales and marketing capabilities across the US to broaden treatment options for patients. We are committed to delivering high-quality, affordable therapies and look forward to this collaboration tailored to driving innovation and improving healthcare accessibility."
The total addressable market opportunity for biosimilar Ranibizumab in the US is approximately US$210 million as per IQVIA MAT Sep 2025.
About Zydus
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 29,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com
About Bioeq
Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Established in 2014, Bioeq specializes in the development, licensing, and commercialization of high-quality biosimilars for highly regulated markets worldwide. The company focuses on creating cost-effective alternatives to leading biologics, ensuring broader patient access to advanced therapies. For more details visit http://www.bioeq.ch
1) Lucentis® is a registered trademark of Genentech, Inc., a member of the Roche Group, South San Francisco, CA/USA.
2) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
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SOURCE Zydus Lifesciences
