Drug intelligence / Profile preview

pegfilgrastim biosimilar B12019

Development stage
Unknown
Lead developer
Mundipharma
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

**Pegfilgrastim biosimilar B12019** (brand name **Pelmeg**) is a biosimilar of pegfilgrastim, developed for the prevention of chemotherapy-induced neutropenia. Pegfilgrastim is a pegylated, long-acting form of recombinant human granulocyte colony-stimulating factor (G-CSF), designed to stimulate bone marrow to increase the production of neutrophils, thereby mitigating the risk of infection in patients undergoing cytotoxic chemotherapy. B12019 has been shown in clinical trials to have pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles highly similar to the reference product Neulasta (Amgen’s pegfilgrastim) in healthy volunteers. Developed by Cinfa Biotech, B12019 was approved in the European Union for the same indications as Neulasta: reduction in the duration of neutropenia and the incidence of febrile neutropenia in adults receiving cytotoxic chemotherapy for malignancy (except for chronic myeloid leukaemia and myelodysplastic syndromes)[2][3][4][5][6].

Brand names
Pelmeg
Other names
pegfilgrastim biosimilar B12019Pelmeg
02

Targets

CSF3R (Granulocyte colony-stimulating factor receptor)

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