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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Published on: May 4, 2017

[Biosimilar filgrastim: from development to record].

P García Alfonso1

  • 1Servicio de Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid, España.

Farmacia Hospitalaria : Organo Oficial De Expresion Cientifica De La Sociedad Espanola De Farmacia Hospitalaria
|October 6, 2010
PubMed
Summary
This summary is machine-generated.

Ratiograstim, a biosimilar to Neupogen, is approved for treating neutropenia and mobilizing progenitor cells. Clinical studies confirm its quality, efficacy, and safety, matching the reference product.

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Area of Science:

  • Biopharmaceuticals
  • Recombinant protein therapeutics
  • Biosimilar drug development

Context:

  • Filgrastim (XM02) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating factor (G-CSF).
  • Ratiograstim is the first filgrastim biosimilar approved by the European Medicines Agency (EMEA).
  • It is compared against the reference medicinal product, Neupogen®.

Purpose:

  • To demonstrate the quality, efficacy, and safety of Ratiograstim® compared to Neupogen®.
  • To gain EMEA authorization for Ratiograstim® via a centralized approval procedure for biosimilars.

Summary:

  • Ratiograstim® shares the same indications as Neupogen®, including chemotherapy-induced neutropenia, neutropenia post-myeloablative therapy, peripheral blood progenitor cell mobilization, congenital/cyclic/idiopathic neutropenia, and persistent neutropenia in HIV patients.
  • Phase I and III clinical studies involving 880 subjects and patients were completed to support the biosimilar approval.
  • Key differences between filgrastim and human G-CSF include an N-terminal methionyl extension and non-glycosylation.

Impact:

  • Establishes Ratiograstim® as a comparable therapeutic option to Neupogen® for various neutropenia conditions.
  • Provides healthcare professionals with a new biosimilar choice, potentially impacting treatment accessibility and cost.
  • Highlights the successful application of EMEA guidelines for biosimilar evaluation.