Lucentis Biosimilar Ranivisio Receives Marketing Authorization from European Commission

Teva Pharmaceuticals announced that it has received marketing authorization from the European Commission for Ranivisio (ranibizumab), a biosimilar of Lucentis. The authorization includes all five indications for which Lucentis is authorized in adults.

Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product. 

“With millions of people in Europe afflicted by this serious age-related eye condition, this important milestone allows us, together with Bioeq, to bring ranibizumab to ophthalmologists and patients throughout Europe," Richard Daniell, Executive Vice President of European Commercial at Teva Pharmaceuticals, said in a company news release. "The product is a welcome addition to Teva’s growing biosimilars portfolio, and delivers on our mission to improve patient access to critical therapies while delivering vital savings to healthcare systems."

Ranivisio is licensed in adults to treat age-related macular degeneration (AMD) and four other ophthalmology indications: visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment resulting from diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularisation.

The authorization comes just weeks after Coherus BioSciences received FDA approval for Cimerli (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis (ranibizumab) for wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV). Cimerli is the only biosimilar product interchangeable with Lucentis across all five indications.

In May, Teva announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) granted a licence for Ongavia, a biosimilar to Lucentis (ranibizumab). The United Kingdom was the first country in Europe to authorize commercialization of Ongavia for the treatment of 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 (DR); 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).

Last year, Samsung Bioepis and Biogen received FDA approval for Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). Byooviz was the first ophthalmology biosimilar approved in the United States.