Pelmeg EU approval : The European Commission (EC) has approved German pharma company Mundipharma’s Pelmeg, a pegylated version of granulocyte-colony stimulating factor (G-CSF) and also a biosimilar to Amgen’s neutropenia medication – Neulasta (pegfilgrastim).
Pelmeg EU approval for Neutropenia
The approval for Pelmeg is for its use as a treatment to bring down the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy. The Mundipharma’s pegfilgrastim biosimilar has not been approved for the treatment of chronic myeloid leukaemia and myelodysplastic syndromes.
Neutropenia is defined as an abnormally low count of a type of white blood cell, called neutrophils, which is important in helping the body fight against infections, especially bacterial infections.
The Pelmeg EU approval was driven by a recommendation for the same from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). It was based on certain crucial biosimilarity data from analytical, biofunctional and clinical study comparisons for the Mundipharma neutropenia medication.
Like Neulasta, Pelmeg has to be subcutaneously injected to the patients. According to Mundipharma, Pelmeg functions by stimulating the bone marrow to generate more neutrophils, thereby bringing down the incidence of infection.
Commenting on Pelmeg EU approval, Philippe Bastide – Head of Biosimilars, Mundipharma International, said: “We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia. The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option.”
Pelmeg is the fourth biosimilar to be brought into the market by the Mundipharma network. The Neulasta biosimilar was developed by biosimilars development company Cinfa Biotech, which was last month acquired by Mundipharma from the Spanish Cinfa Group.
For more pharma regulatory news like Pelmeg EU approval and updates on Mundipharma and Amgen, keep following www.PharmaNewsDaily.com.