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CHMP recommends Abevmy a bevacizumab biosimilar, to treat the indications of Avastin,its originator drug . Mylan/Viatris.
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Abevmy, intended for the treatment of 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. The applicant for this medicinal product is Mylan IRE Healthcare Limited.
Abevmy is a biosimilar medicinal product. It is highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005. Data show that Abevmy has comparable quality, safety and efficacy to Avastin (bevacizumab).
Condition: Colon/NSCLC/Glio/RCC/Cervical
Type: drug