Sandoz is resubmitting its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016, to includes new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study.
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 cells2.
As Novartis noted in its press release, 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 USD 54 billion over 10 year. 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, Novartis said in the statement.
Mark Levick, MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz, said that 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.”
Sandoz is pursuing approval of biosimilar pegfilgrastim to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, Novartis said in the press release.
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 pegfilgrastim6.