CHMP Adopts Positive Opinion For Ranibizumab Biosimilars VISLYFA And REXATILUX

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two ranibizumab biosimilars, VISLYFA and REXATILUX, recommending granting of a marketing authorization.  Ranibizumab is a VEGF-A inhibitor, and can be used to treat macular degeneration via an intravitreal injection; the reference product, LUCENTIS, was authorized by the EU on January 22, 2007.  Six other LUCENTIS biosimilars have been approved in the EU.

Both VISLYFA and REXATILUX are approved for adults with neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and choroidal neovascularisation (CNV).  Intas B2B is the applicant for VISLYFA, and Lupin Europe GmbH is the applicant for REXATILUX.