Epoetin zeta

Drug Profile

Epoetin zeta

Alternative Names: 1-165-Erythropoietin (human clone B03XA01), glycoform zeta; Darbepoetin alfa biosimilar - Bioceuticals; Darbepoetin alfa biosimilar - Hospira; Darbepoetin alfa biosimilar - Stada; Darbepoetin biosimilar - Bioceuticals; Darbepoetin biosimilar - Hospira; Darbepoetin biosimilar - Stada; Epo-zeta; Epoetin alfa biosimilar - Bioceuticals; Epoetin alfa biosimilar - Hospira; Epoetin alfa biosimilar - Stada; Epoetin biosimilar - Bioceuticals; Epoetin biosimilar - Hospira; Epoetin biosimilar - Stada; Epoetin Hospira; Erythropoietin alfa - Bioceuticals; Erythropoietin alfa - Stada; Erythropoietin alfa biosimilar - Hospira; Retacrit; SB 309; Silapo

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator BIOCEUTICALS Arzneimittel
  • Developer Hospira; STADA Arzneimittel
  • Class Antianaemics; Recombinant erythropoietins
  • Mechanism of Action Erythropoiesis stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Anaemia

Most Recent Events

  • 22 Jun 2017 Pfizer receives complete response letter from the FDA for epoetin zeta in Anaemia
  • 25 May 2017 The US FDA Oncologic Drugs Advisory Committee recommends approval of Epoetin zeta for Anaemia in USA
  • 01 Dec 2016 Pfizer resubmits BLA in response to the complete response letter from the FDA for Epoetin zeta in Anaemia
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