EMA accepts Sandoz application for biosimilar to Amgen’s Neulasta cancer drug

Novartis unit Sandoz is seeking approval for the similar indication as the reference product.

The company’s marketing authorization application is supported by three pivotal clinical trials, which demonstrate that the proposed biosimilar is highly similar to the reference product.

Neulasta is a recombinant human granulocyte colony-stimulating factor (G-CSF) that helps reduce the risk of infection by increasing the patient’s white blood cell count to strengthen immune system.

It is used to help reduce the chance of infection because of a low white blood cell count, in people with several types of cancer, who receive anti-cancer medicines that can cause fever and low blood cell count.

Sandoz head of global biopharmaceutical & oncology injectables development Mark McCamish said: "Sandoz is the leading provider of daily G-CSF in Europe and the regulatory filing of our biosimilar pegfilgrastim further cements our commitment to patients undergoing cancer treatment.

"If approved, physicians in the EU will have another high-quality Sandoz biosimilar treatment option for patients needing granulocyte colony-stimulating factors."

Last November, the US Food and Drug Administration accepted Sandoz’s biologics license application submission for a biosimilar version of Neulasta.

In September 2015, Sandoz launched the first biosimilar, Zarxio (filgrastim-sndz), in the US. It is a copycat version of Amgen’s Neupogen cancer drug.