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Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta in Healthy Subjects

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Trial Profile

Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus 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; Pharmacokinetics; 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.
    • 04 Oct 2017 According to a Cinfa Biotech media release, based on the data from this and other study (see profile 276855), the European Medicines Agency (EMA) has accepted Marketing Authorisation Application (MAA) for B12019 to treat chemotherapy-induced neutropenia.
    • 12 Sep 2017 Results of this and other study (NCT02912377), presented at the 42nd European Society for Medical Oncology Congress.
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