MHRA green light for Ongavia, a biosimilar to Lucentis
The UK Medicines and Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia, a biosimilar to Lucentis (ranibizumab), said the product’s developer, Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA).
Lucentis is marketed by Swiss pharma majors Novartis (NOVN: VX) and Roche’s (ROG: SIX).
The UK is the first country in Europe to authorize commercialization of Ongavia for the treatment of neovascular (wet) age-related macular degeneration (AMD). Ongavia is also licenced for: the treatment of visual impairment due to diabetic macular edema (DME); the treatment of proliferative diabetic retinopathy (PDR); the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO); and the treatment of visual impairment due to choroidal neovascularization (CNV).
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