Filgrastim biosimilar: desde el desarrollo al registro

Abstract

Ratiograstim ® is the first filgrastim biosimilar approved by EMEA. The reference medicinal product is Neupogen ®. The active substance is filgrastim (the manufacturing laboratory, ratiopharm, is using the name XM02). Filgrastim is a non glycosylated recombinant methionyl human granulocyte colony stimulating factor expressed in E. coli. Differences with human granulocyte-colony stimulating factor (G-CSF) are a N-terminal methionyl extension and be a non-glycosylated protein. Ratiograstim ® has the same indications as the reference product: – Cytotoxic chemotherapy induced neutropenia. – Neutropenia caused by myeloablative therapy followed by BMT. – Mobilisation of peripheral blood progenitor cells (PBPC). – Congenital, cyclic or idiopathic neutropenia. – Persistant neutropenia in HIV-patients. Authorisation according to the EMEA guidelines for biosimilars by centralized approval procedure, to demonstrate quality, efficacy and safety compared to the reference product Neupogen ®. Comprehensive phase I and phase III clinical studies involving 880 subjects and patients have been completed (table 1).