FDA Approves Sandoz’s Ziextenzo as 24th Biosimilar
The FDA approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), marking the agency’s 24th biosimilar approval and the third biosimilar of Amgen’s Neulasta.
Ziextenzo, a long-lasting form of filgrastim, is indicated to decrease the incidence of infection, as manifested by a low white blood cell count with a fever, in patients with non-myeloid malignancies who take myelosuppressive oncology drugs.
The FDA granted the approval based on the 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 said it plans to launch the biosimilar in the U.S. as soon as possible this year. The drug has been approved in Europe under the same name since 2018, but it faced significant hurdles in the U.S., having received a complete response letter from the FDA in 2016.