CHMP recommends Ranivisio (ranibizumab biosimilar) for treatment of the same indications as Lucentis.- Teva Pharma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ranivisio, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.
The applicant for this medicinal product is Midas Pharma GmbH.
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.
Ranivisio 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 Ranivisio has comparable quality, safety and efficacy to Lucentis (ranibizumab).
Teva Pharmaceutical Industries Ltd. and Bioeq AG announced that they have entered into a strategic partnership for the exclusive commercialization of Bioeq's FYB 201, a biosimilar candidate to Lucentis (ranibizumab) in Europe, Canada, Israel and New Zealand.
Bioeq has in-licensed the exclusive global commercialization rights to FYB 201 from the German biosimilar developer Formycon AG.
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