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A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta in Healthy Adult Subjects

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Trial Profile

A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Sep 2022

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Cancer
  • Focus Pharmacodynamics; Registrational
  • Sponsors Fresenius Kabi; Merck KGaA
  • Most Recent Events

    • 06 Sep 2022 According to a Fresenius Kabi media release, the United States (U.S.) Food and Drug Administration (FDA) has approved Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
    • 27 May 2020 According to a Fresenius Kabi media release, the U.S. Food and Drug Administration has accepted for review the company's Biologics License Application (BLA) for MSB11455, the company's pegfilgrastim biosimilar candidate for Neulasta.The application includes the results of two pivotal clinical trials that showed equivalent pharmacokinetic and pharmacodynamic profiles to the originator Neulasta, as well as similar immunogenicity in healthy volunteers.
    • 22 May 2020 According to a Fresenius Kabi media release, the European Medicines Agency (EMA) has accepted for review, the Marketing Authorization Application (MAA) for MSB11455, based on the data from this trial.
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