CHMP positive recommendation for Afqlir (aflibercept biosimilar)
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Afqlir,(aflibercept biosimilar) intended for the treatment of neovascular (wet) age-related macular degeneration,visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
The applicant for this medicinal product is Sandoz GmbH.
Afqlir will be available as 40 mg/ml solution for injection. The active substance of Afqlir is aflibercept, an antineovascularisation agent (ATC code: S01LA05). Aflibercept is 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.
Afqlir is a biosimilar medicinal product. It is highly similar to the reference product Eylea (aflibercept), which was authorised in the EU on 22 November 2012. Data show that Afqlir has comparable quality, safety and efficacy to Eylea.
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