In India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic to ranibizumab in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion (RVO).
Retinal vein occlusion (RVO) is a common cause of vision loss, and it can be treated with anti—vascular endothelial growth factor therapies such as ranibizumab (Lucentis).
While no biosimilars of ranibizumab are yet approved in the highly regulated territories of the United States or the European Union, in India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and RVO. In a newly published subset analysis of the 160 patients with RVO who were enrolled in RE-ENACT, researchers found that the biosimilar effectively improved visual acuity and disease outcomes in the real-world setting.
The patients, all 18 years or older, received at least 3 ranibizumab injections between January 2016 and August 2016 as part of their routine care for RVO. The primary endpoints of the study were mean change in best corrected visual acuity (BCVA), mean change in central macular thickness (CMT), and the proportion of patients showing intraretinal or subretinal fluid.
The researchers found the following:
“The current subgroup analysis of patients with RVO showed that intravitreal injection of Razumab…is effective in reducing macular thickness and improving visual acuity in the real-world setting,” conclude the authors.
Reference
Sharma S, Khan MA, Chaturvedi A. Real-life clinical effectiveness of Razumab (the world’s first biosimilar of ranibizumab) in retinal vein occlusion: a subgroup analysis of the pooled retrospective RE-ENACT Study. Ophthalmologica. 2018;26:1-8. doi: 10.1159/000488602.
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