Sandoz resubmits BLA for biosimilar pegfilgrastim to the FDA

Sandoz, a Novartis division and a global leader in biosimilars, announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the FDA to address an FDA complete response letter received in June 2016. Pegfilgrastim is a long-acting version of filgrastim and may be prescribed to appropriate cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells.

Studies have shown that, each year in the US, 4,000 cancer patients die of febrile neutropenia and 60,000 are hospitalized due to neutropenia. Biosimilars help create the potential to save the US healthcare system up to $54 billion over 10 years. Access to more treatment options for neutropenia is urgently needed, as cancer-related neutropenia hospitalizations can amount to as much as $ 2.3 billion in costs per year.

The resubmission includes new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study. This was a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.