Israeli drug manufacturer Teva Pharmaceutical Industries Ltd. (TEVA) announced Monday that the European Commission has granted a Marketing Authorization for Ranivisio (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentisis authorized.
The approval is for the treatment of age-related macular degeneration or AMD, the most common cause of blindness in developed countries.
Ranivisio is developed by Swiss biopharmaceutical joint venture Bioeq AG, licensed by Teva. Bioeq is a joint venture between the Polpharma Biologics Group and Formycon AG.
Lucentis is developed by Genentech Inc., a Roche company.
AMD, a leading cause of blindness for working age adults with uncontrolled diabetes, is caused by excessive growth of blood vessels in the retina that leads to visual impairment. Ranibizumab inhibits vascular endothelial growth factor or VEGF, which is responsible for the excessive formation of these blood vessels in the retina.
It is estimated that up to 77 million Europeans will be affected with AMD by 2050.
Ranivisio is licensed in adults to treat AMD and four other ophthalmology indications.
The approval was based on COLUMBUS-AMD study, a randomized, double-masked, parallel group, multi-centre phase III study, in which ranibizumab was shown to be highly similar to its reference medicine in terms of clinical efficacy and ocular and systemic safety in the treatment of AMD and its other ophthalmology indications.
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