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Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

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Trial Profile

Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2019

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Febrile neutropenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Mylan

    • Most Recent Events

    • 01 May 2019 Results published in the Annals of Hematology
    • 30 Nov 2018 According to a Biocon media release, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted Marketing Authorization for Fulphila indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy. The approval has been granted to Mylan.
    • 21 Sep 2018 According to a Mylan media release, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen's Neulasta (pegfilgrastim). The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity. The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018.

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