CHMP recommendation for Ranibizumab Midas, ranibizumab 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 Ranibizumab Midas, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation
The applicant for this medicinal product is Midas Pharma GmbH.
Ranibizumab Midas will be available as a 10 mg/ml solution for injection. The active substance of Ranibizumab Midas is ranibizumab, a monoclonal antibody fragment (ATC code: S01LA04) which modulates angiogenesis by inhibiting vascular endothelial growth factor A.
Ranibizumab Midas is a biosimilar medicinal product. It is highly similar to the reference product Lucentis (ranibizumab), which was authorised in the EU on 22/01/2007. Data show that Ranibizumab Midas has comparable quality, safety and efficacy to Lucentis (ranibizumab).
Ranibizumab Midas is a duplicate of Ranivisio, which was authorised in the EU on 25 August 2022. Duplicate medicines have identical composition and pharmaceutical form.
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