Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed by Bioeq (which is a joint venture between Formycon and Polpharma Biologics). Ranivisio is EC approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
Earlier this month, Coherus announced the US approval of Cimerli™ with interchangeability designation, which Bioeq licensed to Coherus for the US. The Bioeq product was also approved in the UK in May 2017 as Teva’s Ongavia®.