Sandoz resubmits BLA for biosimilar pegfilgrastim to FDA

Novartis unit Sandoz has resubmitted a biologics licence application (BLA) of its proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) seeking approval to address febrile neutropenia in cancer patients.

Sandoz initially submitted the BLA in November 2015 and the latest filing is to address the complete response letter issued by FDA in June 2016.

The company’s product is a biosimilar to Amgen’s Neulasta (pegfilgrastim), which is a recombinant human granulocyte colony-stimulating factor (G-CSF).

Pegfilgrastim is a long-acting version of filgrastim and designed to mitigate the duration of neutropenia and febrile neutropenia. The former presents as a low white blood cell count while the latter is characterised by low white blood cell count with a fever.

The therapy is intended to help reduce the risk of infection due to neutropenia in cancer patients undergoing chemotherapy by increasing the generation of white blood cells.

In the new submission, Sandoz included data obtained during a pivotal, single-dose, three-period cross-over pharmacokinetics (PK) and pharmacodynamics (PD) study.

"In the US, febrile neutropenia is responsible for 4,000 cancer patient deaths and neutropenia leads to 60,000 are hospitalisations each year."

The study compared Sandoz pegfilgrastim with US- as well as EU-sourced reference pegfilgrastim, and also the US-sourced product with EU-sourced reference pegfilgrastim.

Sandoz Biopharmaceuticals development global head Mark Levick said: "The US market is just beginning to benefit from biosimilars, as shown by the success of our filgrastim, the first approved biosimilar in the US.

"The submission of our pegfilgrastim biosimilar application is another step for us as we continue to lead the way in creating early and expanded patient access to life-changing biologics."

Previous studies revealed that in the US febrile neutropenia is responsible for 4,000 cancer patient deaths and neutropenia leads to 60,000 are hospitalisations each year.

Sandoz noted that cancer-related neutropenia hospitalisations can cost nearly $2.3bn annually, creating the need for access to more treatment options.

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