On 14 November and 12 December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for three aflibercept biosimilars: Baiama, its duplicate, Ahzantive, and Eydenzelt.
Ahzantive/Baiama and Eydenzelt are biosimilars referencing Regeneron and Bayer’s Eylea (aflibercept). Ahzantive/Baiama are developed by Formycon under the designation of FYB203, and Eydenzelt (CT-P42) by Celltrion.
These biosimilars are approved for the treatment of age-related neovascular (wet) macular degeneration (nAMD), and visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema or myopic choroidal neovascularisation.
The CHMP’s positive opinion of FYB203 was based on a comprehensive data package, including analytical, pre-clinical, clinical and manufacturing data, demonstrating that Ahzantive/Baiama are comparable in quality, efficacy, safety, and immunogenicity to Eylea in patients with nAMD.
In a Phase III study of Eydenzelt, the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt was compared to Eylea in patients with diabetic macular oedema (DME), demonstrating therapeutic equivalence to Eylea by meeting the predefined equivalence criteria.
Ahzantive/Baiama will be available as 40 mg/mL solution for injection, and Eydenzelt will be available as 40 mg/mL solution for injection in pre-filled syringe and vial.
Klinge Biopharma GmbH holds the marketing authorization for Baiama, while Formycon is responsible for Ahzantive’s marketing authorization.
Ahzantive was approved as the third aflibercept by FDA on 28 June 2024 [1].
Klinge Biopharma also has an exclusive licensing and supply agreement with MS Pharma for FYB203’s commercialization in the Middle East and North Africa (MENA) region [2].
These biosimilars are now pending a decision from European Commission regarding central marketing authorization, which is expected in early 2025.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [3], a recombinant fusion protein consisting of the extracellular domains of human VEGF receptor 1 and 2 fused to the Fc portion of human IgG1. By acting as a soluble decoy for the natural VEGF receptors, aflibercept inhibits their activation, thereby reducing angiogenesis.
As of September 2024, three other aflibercept biosimilars have already been approved in the European Union: Sandoz’s Afqlir and Samsung Bioepis’ Opuviz, both approved in September 2024 [4], and Biocon’s Yesafili, approved in 2023 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 7]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive
2. GaBI Online - Generics and Biosimilars Initiative. Klinge–MS Pharma and Teva–mAbxience biosimilars licence agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 7]. Available from: www.gabionline.net/pharma-news/klinge-ms-pharma-and-teva-mabxience-biosimilars-licence-agreements
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 7]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 7]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-aflibercept-biosimilars-afqlir-and-opuviz
5. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 7]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
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