New Filgrastim Biosimilar Approved by FDA

The FDA has approved pegfilgrastim-bmez (Ziextenzo, Sandoz) to decrease the incidence of infection from febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs associated with a high incidence of febrile neutropenia. 

Pegfilgrastim-bmez is a long-acting biosimilar to filgrastim, a leukocyte growth factor similar to the granulocyte colony-stimulating factor protein. The recent approval marks the fourth filgrastim biosimilar approved under the Sandoz label. 

“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” said Carol Lynch, president of Sandoz Inc, 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.”

Trending: Study: Walking Speed Might Affect Cancer Outcomes

The approval is based upon results from a three-way pharmacokinetics and pharmacodynamics study, according to the news release. After comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-Sourced reference pegfilgrastim, researchers found enough similarity between the pharmacokinetics and pharmacodynamics results to warrant safety and efficacy. 

Pegfilgrastim-bmez is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (i.e., Pegfilgrastim or Filgrastim products). 

Warnings and precautions issued with the use of pegfilgrastim-bmez include fatal splenic rupture; acute respiratory distress syndrome; and serious allergic reactions including anaphylaxis, fatal sickle cell crises, and glomerulonephritis.

Adverse reactions reported with the use of pegfilgrastim-bmez include pain in the bones and extremities. 

Full Prescribing Information