EU approves Ranivisio for serious retinal diseases.- Formycon, Polpharma Biologics and Bioeq
The EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio is highly similar to the reference product Lucentis in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration.
EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Ranivisio will be available as a 10 mg/ml solution for injection. The active substance of Ranivisio is ranibizumab, a monoclonal antibody fragment (ATC code: S01LA04) which modulates angiogenesis by inhibiting vascular endothelial growth factor A.
Lucentis patents expired in the US in 2020 and will expire in the EU in 2022.
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