EU regulators to review Sandoz’ Neulasta biosimilar

The European Medicines Agency has accepted for review Novartis unit Sandoz’ biosimilar of Amgen’s Neulasta.

Neulasta (pegfilgrastim) is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor), and Sandoz is seeking approval for use of its biosimilar in the same indication, that is to help reduce the risk of infection due to a low white blood cell count in patients with non-myeloid cancer who receive chemotherapy.

Novartis and Sandiz withdraw their original marketing application for their biosimilar earlier this year, after the European Medicines Agency’s Committee for Medicinal Products for Human Use raised questions on efficacy and manufacturing.

Sandoz says the re-submission includes analytical, preclinical and clinical data that "strongly demonstrates" that its biosimilar pegfilgrastim "matches the reference medicine in terms of safety, efficacy and quality".

"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," noted Mark Levick, global head of development, at Sandoz Biopharmaceuticals.

The biosimilar was rejected by regulators in the US last year, but is expected to be re-filed there in the first half of next year.