EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

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EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

Biosimilares/Novedades | Posted 23/10/2024 0 Post your comment

On 19 September 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 two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [1], 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.

Both Afqlir and Opuviz are approved for the treatment of:

Neovascular (wet) age-related macular degeneration (AMD)
Macular oedema following retinal vein occlusion (branch RVO or central RVO)
Diabetic macular oedema (DME)
Myopic choroidal neovascularisation (myopic CNV)

The CHMP’s positive opinion of Opuviz was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL).

Both Afqlir and Opuviz are available as 40 mg/mL solution for injection in a vial.

The first aflibercept biosimilar approved in Europe was Biocon’s Yesafili on 15 September 2023 [2]. With the approvals of two new aflibercept biosimilars, Afqlir and Opuviz, there are now three aflibercept biosimilars available in Europe.

Afqlir and Opuviz have already been approved by the FDA. Opuviz was approved as the first interchangeable biosimilar to Eylea in May 2024 [3]. Sandoz’s aflibercept biosimilar is called Afqlir in Europe and Enzeevu in the US [4]. Three other aflibercept biosimilars have been approved by the FDA: Yesafili (aflibercept-jbvf) [3], Ahzantive (aflibercept-mrbb) [5], and Pavblu (aflibercept-ayyh) [4]. This brings the total to five aflibercept biosimilars approved in the US to date.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
2. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-aflibercept-biosimilars-to-treat-macular-degeneration
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves aflibercept biosimilars Enzeevu and Pavblu [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-aflibercept-biosimilars-enzeevu-and-pavblu
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive

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