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Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta in Healthy Subjects

Trial Profile

Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Feb 2019

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Registrational
  • Sponsors Cinfa Biotech
  • Most Recent Events

    • 23 Nov 2018 According to a Mundipharma GmbH media release, the EC has granted approval for the use of Pelmeg (pegfilgrastim) as a treatment for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy.The ECs decision follows a recommendation from the CHMP that was based on a robust regulatory submission of key biosimilarity data from analytical, biofunctional and clinical study comparisons for Pelmeg.
    • 12 Dec 2017 Results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 02 Nov 2017 According to a Cinfa Biotech media release, new data will be presented at the 59th American Society of Hematology (ASH) Annual Meeting 2017.
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