Samsung Bioepis Monday announced that the European Commission has granted marketing approval to its biosimilar drug referencing Lucentis (ranibizumab).
The EC authorization of the drug named Byooviz comes about two months after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the biosimilar.
Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. It has been used for the treatment of age-related macular degeneration and visual impairment due to diabetic macular edema.
Lucentis from Roche and Novartis is a blockbuster drug that generated about $4 billion in worldwide sales last year.
Samsung Bioepis has a biosimilar pipeline of 10 products and candidates. In Europe, the company has distributed three autoimmune disease products and two oncology products.
By Kim Si-gyun and Minu Kim
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