Posted by Michael Wonder on 25 Nov 2018
European Commission approves Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy
23 November 2018 - Pelmeg was developed by Cinfa Biotech, now part of the Mundipharma network of independent associated companies.
The Mundipharma network of independent associated companies today announced that the European Commission has granted approval for the use of Pelmeg (pegfilgrastim) as a treatment for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
The EC’s decision follows a recommendation from the CHMP that was based on a robust regulatory submission of key biosimilarity data from analytical, biofunctional and clinical study comparisons for Pelmeg. In all cases it demonstrated comparable pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product Neulasta.
