MHRA (UK) approves Ongavia a biosimilar to Lucentis for neovascular (wet) age-related macular degeneration.- Teva Pharma
Teva Pharmaceutical Industries Ltd welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia, a biosimilar to Lucentis® (ranibizumab ), an eye injection. The United Kingdom 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 oedema (DME); the treatment of proliferative diabetic retinopathy (PDR); the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and the treatment of visual impairment due to choroidal neovascularisation (CNV).
Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina2. Teva's biosimilar ranibizumab is highly similar to its reference medicine in terms of clinical efficacy, ocular and systemic safety in the treatment of patients with AMD and its other indications, as shown in the COLUMBUS-AMD study (a randomized, double-masked, parallel group, multi-centre phase III study).
The patents on Lucentis expired in the US in June 2020 and will expire in Europe in 2022.
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