On 18 December 2025, the US Food and Drug Administration (FDA) granted approval to Nufymco (ranibizumab-leyk), an interchangeable biosimilar to Genentech’s Lucentis (ranibizumab).
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].
Developed by Formycon and Bioeq, Nufymco (ranibizumab-leyk) is the third interchangeable ranibizumab biosimilar approved in the US, a designation that allows pharmacists to substitute it for the reference product without prescriber intervention, subject to state law.
Nufymco (ranibizumab-leyk) is approved for the full range of Lucentis indications, including:
- Neovascular (wet) age-related macular degeneration (AMD)
- Macular oedema following retinal vein occlusion (RVO)
- Diabetic macular oedema (DME)
- Diabetic retinopathy (DR)
- Myopic choroidal neovascularization (mCNV)
The therapy will be available as a single-dose vial injection in 6 mg/mL and 10 mg/mL concentrations, aligning with the dosing options of the reference product to facilitate seamless integration into clinical practice.
Zydus Lifesciences will exclusively commercialize Nufymco in the U.S., leveraging its expertise in ‘Part B’ drug distribution. The partnership builds on a recent agreement for Zydus to also commercialize Formycon's Keytruda biosimilar (FYB206) in the US and Canada.
Nufymco represents Formycon’s second FDA-approved biosimilar, following Ahzantive (aflibercept-mrbb), a biosimilar to Eylea, which was approved in June 2024 [2].
The interchangeable ranibizumab landscape in the US
Nufymco joins the existing US market for interchangeable ranibizumab biosimilars:
- Byooviz (ranibizumab-runa) from Samsung Bioepis [3]
- Cimerli (ranibizumab-eqrn), developed by Formycon/Bioeq, had its U.S. commercialization rights acquired by Coherus in 2019. Sandoz subsequently acquired the Cimerli asset from Coherus in January 2024 and now markets the product [4, 5]
The entry of a third interchangeable biosimilar is expected to further intensify competition in the ranibizumab market, which could drive down costs and expand patient access to this critical class of anti-VEGF therapies for retinal diseases.
Related articles
Formycon signs new aflibercept biosimilar pacts and launches ranivisio in Europe
Global partnerships for biosimilar commercialization announced
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Feb 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Feb 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Feb 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Feb 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
5. GaBI Online - Generics and Biosimilars Initiative. Sandoz US acquisition of ranibizumab biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Feb 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
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