European Commission Approves Pegfilgrastim Biosimilars

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim).

First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech.  According to Mundipharma, the product is approved for the “use of Pelmeg▼® 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.)”

Second, today the EC approved Sandoz’s pegfilgrastim biosimilar (Ziextenzo®), indicated “to reduce duration of neutropenia / incidence of febrile neutropenia, some of the most serious side effects of chemotherapy.”

Download PDF