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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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.
With ambitions to file biosimilar ranibizumab and initiate one new development program per year, Sweden’s Xbrane Biopharma has brought in millions of much needed fresh capital to fuel operations.