AcellBia rituximab regulatory update

Biocad said the Russian Ministry of Health approved the company's AcellBia, a biosimilar of rituximab for autoimmune and cancer indications. Biocad said AcellBia is the first mAb biosimilar to be approved in Russia. The company expects pricing of the product will be set by the Russian government in the next 2-3 months. The chimeric mAb against CD20 antigen is approved in the EU in combination with glucocorticoids to induce remission in adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis and to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), diffuse large B cell lymphoma (DLBCL) and rheumatoid arthritis (RA). ...