Sandoz Receives FDA Approval for Pegfilgrastim Biosimilar

Officials with the FDA today approved pegfilgrastim-bmez (Ziextenzo, Sandoz), a biosimilar to pegfilgrastim (Neulasta), according to a press release.

Pegfilgrastim-bmez has already been approved and marketed in Europe since 2018.

Pegfilgrastim is indicated to decrease the incidence of febrile neutropenia, a serious adverse effect of chemotherapy, in patients with non-myeloid malignancies. Each year, more than 60,000 US patients with cancer are hospitalized with evidence of neutropenia, including fever or infection, with more than 4000 deaths as a result, according to Sandoz.

With this approval, Sandoz, which also manufactures a filgrastim (Zarxio) biosimilar, will now offer US health care providers both short- and long-acting biosimilar options to best suit the individual needs of patients with cancer, according to the release.

The approval was based on data from a 3-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104). The study compared pegfilgrastim-bmez with US-sourced reference pegfilgrastim, pegfilgrastim-bmez with European Union (EU)-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim.

Across all 3 comparisons, PK and PD similarity were demonstrated and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.

“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” Carol Lynch, president of Sandoz Inc said in a statement. “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio—the leading filgrastim by market share in the US—including consistent product supply and reliable patient services.”

According to Sandoz, the company intends to launch pegfilgrastim-bmez in the United States as soon as possible this year.

Reference

Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez) [news release]. Sandoz website. https://www.sandoz.com/news/media-releases/sandoz-receives-us-fda-approval-long-acting-oncology-supportive-care-biosimilar. Accessed November 5, 2019.