EU approves Alymsys for 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.- Mabxience

The European Commission (EC) has approved mAbxience's MB02 biosimilar to Avastin (Bevacizumab), in Europe. MB02, to be commercialized as Alymsys and Oyavas, is highly similar to the reference medicinal product and data has shown a comparable quality, safety and efficacy to Avastin. MB02 is 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.Alymsys will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Alymsys is bevacizumab, a monoclonal antibody (ATC code: L01XC07). It binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby inhibiting the binding of VEGF to its receptors on the surface of endothelial cells. Neutralising the biological activity of VEGF reduces vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.