Pelmeg®

 

 

Pelmeg is a pegfilgrastim biosimilar and is indicated for the reduction of 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).1

Pegfilgrastim is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the duration of neutropenia and the incidence of febrile neutropenia. It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy. 1

The approval of Pelmeg was based on a robust regulatory submission of rigorous analytical, biofunctional, preclinical and clinical studies to demonstrate biosimilarity in terms of its quality, safety and efficacy profile compared with the reference pegfilgrastim. As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) reference pegfilgrastim.2

References

  1. Pelmeg® (pegfilgrastim) Summary of Product Characteristics. Available at: www.medicines.ie
  2. European Medicines Agency. Pelmeg® (pegfilgrastim) European Public Assessment Report. Available at: https://www.ema.europa.eu/documents/assessment-report/pelmeg-epar-public-assessment-report_en.pdf