Ranibizumab (Genentech)

NUFYMCO® BLA has been approved by the USFDA AHMEDABAD, India and ZUG, Switzerland, Dec. 23, 2025 /PRNewswire/ -- 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 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 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. Logo: SOURCE Zydus Lifesciences 21% more press release views with Request a Demo

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ® pre-filled syringe (PFS), a biosimilar referencing Lucentis1 (ranibizumab). BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). As Samsung Bioepis starts to commercialize BYOOVIZ in January 2026, the addition of this PFS presentation will provide additional value for our stakeholders, by helping providers manage ophthalmic conditions with convenience for injection. The PFS presentation is regarded as the standard of care in ophthalmology, providing convenience for administration with precise dosing and ease of use with syringe injection, as well as safety benefits in the form of a decreased risk of endophthalmitis versus vials.2 “As Samsung Bioepis starts to commercialize BYOOVIZ in January 2026, the addition of this PFS presentation will provide additional value for our stakeholders, by helping providers manage ophthalmic conditions with convenience for injection,” said Antonio Rito, Vice President and Head of Europe at Samsung Bioepis. “We will continue to provide biosimilar medicines with improved product features to meet the needs of healthcare providers and patients.” In October 2025, Samsung Bioepis announced that the company will assume full commercial responsibility for BYOOVIZ in Europe upon full transition of Biogen’s commercialization rights back to Samsung Bioepis effective as of January 2026. The PFS presentation is expected to be available in the market starting in the second quarter of 2026. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on social media – LinkedIn, X. 1 Lucentis is a trademark of Genentech Inc. 2 Uzzan J, Mapani A, Cox O, Bagijn M, Saffar I. Clinical Outcomes and Experiences with Prefilled Syringes Versus Vials for Intravitreal Administration of Anti-VEGF Treatments: A Systematic Review. Ophthalmol Ther. 2024 Sep;13(9):2445-2465. doi: 10.1007/s40123-024-01002-0. Epub 2024 Jul 27. PMID: 39066961; PMCID: PMC11341511.