FDA Approves Another Interchangeable Ranibizumab Biosimilar, Nufymco – Strengthening US Presence With Zydus As Commercialization Partner

• FDA approves Biologics License Application (BLA) for additional ranibizumab biosimilar under the trade name Nufymco
• Zydus becomes commercialization partner for Nufymco in the US
• Targeted strategy to maximize market penetration for ranibizumab biosimilars by building further on existing partnerships

Formycon AG (“Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco¹ (ranibizumab-leyk), an interchangeable biosimilar to Lucentis². With its second FDA-approved ranibizumab biosimilar in the US, the companies are further underscoring their pioneering position in high-quality biosimilar development.

Zydus Lifesciences Limited (including its subsidiaries and affiliates; “Zydus”) has been secured as another strong commercialization partner for the US market. The company has proven expertise with medically administered drugs (known as Medical Part B), a category that includes Nufymco. Recently, Zydus also obtained exclusive rights to Formycon’s Keytruda³ biosimilar FYB206 for the US and Canada – a strong testament to the attractiveness of and confidence in Formycon’s development platform.

Nufymco is an interchangeable biosimilar to Lucentis, developed by Formycon, and will be available in the US for all approved indications, expanding access to essential retinal therapies by offering a more affordable treatment option for patients.

“Our FDA approval for Nufymco marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development. With two strong and internationally established partners, we are ideally positioned to expand access to high-quality and affordable ranibizumab biosimilars for ophthalmic patients in the US. This expanded market coverage opens new growth opportunities by enabling a differentiated approach within the complex US healthcare and reimbursement landscape, supporting sustainable market penetration,” comments Dr. Stefan Glombitza, CEO of Formycon AG.

Nufymco is FDA approved for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

¹ Nufymco is a registered trademark of Formycon AG
² Lucentis is a registered trademark of Genentech, Inc.
³ Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.

About Formycon
Formycon AG is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich. For more information, visit https://www.formycon.com/

About Bioeq
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses, and markets biosimilars. For more information, visit www.bioeq.ch

About Zydus Lifesciences Limited
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 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more information, visit www.zyduslife.com

About Biosimilars
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.