Samsung Bioepis Backed By EMA For First Lucentis Biosimilar
Byooviz Ranibizumab Biosimilar Recommended By EMA’s CHMP
Samsung Bioepis is set to make waves with the first ophthalmic biosimilar after the European regulator recommended that its ranibizumab biosimilar Byooviz receive a pan-European marketing authorization.
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Formycon has seen its FYB201 ranibizumab biosimilar rival to Lucentis recommended for approval by the EMA’s CHMP, under the name Ranivisio. Teva has rights to market the product in Europe and is preparing for launch.
Samsung Bioepis has seen a positive opinion in the EU for its Byooviz (ranibizumab) biosimilar treatment for wet age-related macular degeneration turned into final approval by the European Commission. The company is also leading the pack in the US.
Roche insisted that “biosimilar competition is only one factor in the overall picture,” as it reported another set of depleted figures for its three powerhouse biologic brands: Avastin, MabThera/Rituxan and Herceptin.