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  • Title: [Biosimilar filgrastim: from development to record].
    Author: García Alfonso P.
    Journal: Farm Hosp; 2010 Mar; 34 Suppl 1():19-24. PubMed ID: 20920854.
    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).
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