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Spring 2020 - Safety

FDA Approves Sandoz’s Ziextenzo as 24th Biosimilar

The U.S. Food and Drug Administration (FDA) has approved Ziextenzo (pegfilgrastim-bmez), the 24th biosimilar approval in the U.S. and the third biosimilar of Amgen’s Neulasta. Ziextenzo is a long-lasting form of filgrastim indicated to decrease the incidence of infection, as manifested by a low white blood cell count with fever, in patients with nonmyeloid malignancies who take myelosuppressive oncology drugs. Approval was granted based on results of a three-way pharmacokinetics and pharmacodynamics study in which no clinically meaningful differences were seen for safety and immunogenicity between the drug and other versions of pegfilgrastim. Sandoz launched the biosimilar in the U.S. in late 2019. It has been approved in Europe under the same name since 2018.

References

FDA Approves Sandoz’s Ziextenzo as 24th Biosimilar. U.S. Food and Drug Administration press release, Nov. 15, 2019. Accessed at www.fdanews.com/articles/193451-fda-approves-sandozs-ziextenzo-as-24th-biosimilar.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.