Sandoz announced its biosimilar to EU-authorized Neulasta (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.
Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine.
"Our goal is to improve patient access to important biologic medicines and the EMA file acceptance of our biosimilar pegfilgrastim is a move towards doing just that," said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals.
The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.
The clinical development program for Sandoz biosimilar pegfilgrastim includes data from Phase I pharmacokinetic and pharmacodynamic studies in healthy volunteers, as well as Phase III confirmatory safety and efficacy studies in breast cancer patients.
Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.