EMA CHMP Recommends Grant of Marketing Authorization for Three Biosimilars



The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products.  On June 23, 2022, CHMP recommended the grant of a marketing authorization for RANIVISIO (ranibizumab) to Midas Pharma GmbH.  RANIVISIO references LUCENTIS® and, if approved, would be used to treat neovascular (wet) age-related macular degeneration, visual impairment due to macular edema or choroidal neovascularization, and proliferative diabetic retinopathy.  RANIVISIO will be available as a 10 mg/ml solution for injection.

On the same day, CHMP also recommended grant of a marketing authorization for VEGZELMA (bevacizumab) to Celltrion Healthcare Hungary Kft.  VEGZELMA references AVASTIN® and, if approved, would be used to treat carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.  VEGZELMA will be available as a 25 mg/ml concentrate for solution for infusion. This represents Celltrion’s third oncology biosimilar to be recommended for marketing authorization by the EMA.

On June 24, 2022, Formycon and its licensing partner Bioeq AG reported that CHMP also recommended grant of a marketing authorization for FYB201 (ranibizumab).  FYB201 references LUCENTIS® and, if approved, would be used to treat age-related neovascular (wet) macular degeneration (AMD) and other serious ocular diseases such as diabetic macular edema (DME) proliferative diabetic retinopathy (PDR), macular edema due to retinal vein occlusion (branch RVO or central RVO) and choroidal neovascularization (CNV).

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