Mundipharma's Neulasta biosimilar approved by EC

The Mundipharma network of independent associated companies today announced that the European Commission (EC) has granted approval for the use of Pelmeg (pegfilgrastim), which will enter a potential global market worth $4.5 billion.

As is the reference product, Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim), Pelmeg is approved 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 leukemia and myelodysplastic syndromes).

The EC’s decision follows a recommendation from the Committee for Medicinal Products for Human Use (CHMP) in September 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.  The information submitted, and conclusions reached, were comprehensive enough to extrapolate the indication for Neulasta across to Pelmeg. As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta.