EC Authorizes Ranivisio, a Lucentis Biosimilar

The European Commission (EC) has granted marketing authorization to Ranivisio (ranibizumab), a biosimilar of Genentech and Novartis’ Lucentis, for treatment of several retinal diseases.

The biosimilar was developed by Polpharma Biologics and Formycon through their joint venture Bioeq.

Ranivisio is specifically indicated for neovascular age-related macular degeneration, visual impairment due to diabetic macular edema or choroidal neovascularization, proliferative diabetic retinopathy and visual impairment due to macular edema secondary to retinal vein occlusion.

The EU authorization followed a positive opinion from the EMA’s Committee for Medicinal Products for Human Use in June.

Polpharma Biologics and Formycon have granted Teva rights to commercialize the product in Europe and several other countries. Teva plans to launch the drug in the Europe in the coming year.