European Commission approves biosimilar Ziextenzo to treat neutropenia.-Sandoz

Sandoz, Novartis division and the pioneer and global leader in biosimilars, announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo (pegfilgrastim). Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes. These indications match those of the reference medicine.

This approval was based on comprehensive analytical, preclinical and clinical data. In these studies, Ziextenzo matched the reference medicine in terms of safety, efficacy and quality. Pegfilgrastim, the active substance in Ziextenzo, is a long-acting form of filgrastim, which stimulates the production of white blood cells.