European Fee grants marketing authorization for Ranivisio▼®* (ranibizumab), a biosimilar to Lucentis®**, for age-similar macular degeneration (AMD) the most common trigger of blindness in developed nations around the world

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TEL AVIV, Israel–(Small business WIRE)–Teva Pharmaceutical Industries Ltd. announces that the European Commission (EC) has granted a Marketing and advertising Authorization for Ranivisio (ranibizumab), a biosimilar of the ophthalmology remedy Lucentis throughout all 5 indications in grown ups for which Lucentis is licensed.

Richard Daniell, Government Vice President, European Commercial, Teva Prescription drugs commented: “With hundreds of thousands of people in Europe stricken by this major age-linked eye problem this crucial milestone makes it possible for us, with each other with Bioeq, to deliver ranibizumab to ophthalmologists and clients all over Europe. The solution is a welcome addition to Teva’s escalating biosimilars portfolio, and delivers on our mission to increase client accessibility to significant therapies even though providing essential financial savings to healthcare devices.”

Ranivisio is certified in grown ups to treat age-related macular degeneration (AMD) and 4 other ophthalmology indications: visible impairment because of to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment resulting from diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularisation (CNV).

All around 67 million persons in Europe are afflicted by AMD. It is a main induce of blindness for performing age grown ups with uncontrolled diabetes3, and the most common bring about of blindness in produced countries2. It is estimated that up to 77 million Europeans will be affected with AMD by 20504.

AMD is induced by too much development of blood vessels in the retina that qualified prospects to visual impairment and can even bring about blindness. Ranibizumab inhibits vascular endothelial advancement element (VEGF), which is responsible for the abnormal development of these blood vessels in the retina5.

In the COLUMBUS-AMD research, a randomized, double-masked, parallel group, multi-centre stage III research6, ranibizumab was proven to be remarkably similar to its reference drugs in conditions of medical efficacy and ocular and systemic safety in the treatment of AMD and its other ophthalmology indications.

* Ranivisio is a registered trademark of Bioeq AG, licensed by Teva

** Lucentis® is…

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