FDA accepts Sandoz regulatory submission for a biosimilar of cancer drug pegfilgrastim

The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF).

Sandoz, a Novartis company and biosimilars specialist, in an announcement on Wednesday added that it was seeking approval for the same indication as the reference product.

Pegfilgrastim is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in patients with cancer (non-myeloid) who receive chemotherapy that can cause fever and a low blood cell count (febrile neutropenia).

“The FDA’s acceptance of our regulatory submission for biosimilar pegfilgrastim – our third biosimilar filed in the US – demonstrates our commitment to expanding patient access to biologics in the US” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz.

“If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors,” McCamish added.

Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients – will demonstrate that the proposed biosimilar is highly similar to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product’s indication.