Mundipharma has revealed that Pelmeg, its biosimilar version of Amgen’s Neulasta (pegfilgrastim), has been awarded marketing approval by the European Commission.
The decision was driven by a “a robust regulatory submission” of data which supported the biosimilarity of Pelmeg to its reference product, demonstrating non-inferiority in pharmacodynamics, pharmacokinetics, and immunogenicity. It also follows a positive recommendation to approve the product from the Committee for Medicinal Products for Human Use (CHMP).
