Sandoz resubmits biosimilar pegfilgrastim application to US FDA

On Apr 4, 2019

Sandoz, a Novartis division and a global leader in biosimilars, today resubmission of 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.

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 USD 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 USD 2.3 billion in costs per year.

“For the tens of thousands of US cancer patients undergoing chemotherapy, treatment options that can be individualized right from the start, such as long- and short-acting filgrastim biosimilars, are key to help manage the risk of serious complications related to infection,” said Mark Levick, MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz.

He added: “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 biosimilar pegfilgrastim is designed to match the reference medicine. 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.

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.

Sandoz is focused on strengthening its portfolio in oncology care and remains well-positioned as a leader in the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Sandoz has three approved biosimilars in the US and markets eight biosimilars in the European Economic Area (EEA), including biosimilar pegfilgrastim.