FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration

Biosimilares/Novedades | Posted 19/06/2024 post-comment0 Post your comment

On 20 May 2024, the US Food and Drug Administration (FDA) approved Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Regeneron and Bayer's Eylea (aflibercept). The Samsung Bioepis product has also been launched in South Korea under brand name, Afilivu.

VEGF allaboutvision.com V21D02

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [1], a recombinant fusion protein consisting of human VEGF receptor 1 and VEGF receptor 2 extracellular domains fused to the Fc portion of human IgG1 which acts as a soluble decoy for the natural VEGF receptors that inhibits their activation, thereby reducing pathological angiogenesis.

Both Yesafili and Opuviz are used to treat:

  • Neovascular (wet) age-related macular degeneration
  • Macular oedema following retinal vein occlusion
  • Diabetic macular oedema
  • Diabetic retinopathy

Both Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the conditions listed above, according to dosing regimens recommended in the labelling. Yesafili was approved in Europe in September 2023, and Biocon is set to commercialize its biosimilars in 31 European countries [2, 3]. 

In South Korea, Afilivu (aflibercept), an Eylea biosimilar, was launched on 1 May 2024. This is Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis (ranibizumab) biosimilar, Amelivu, launched in Korea in 2023 [4].  

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. 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 Jun 19]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biocon to commercialize biosimilars in 31 European countries biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/pharma-news/biocon-to-commercialize-biosimilars-in-31-european-countries
4. GaBI Online - Generics and Biosimilars Initiative. Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/news/ranibizumab-biosimilar-ximluci-and-amelivu-to-launch-in-the-uk-and-south-korea

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