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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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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Immunological memory, a pivotal pillar of the adaptive immune system, is responsible for the body's ability to remember and respond more swiftly and effectively to previously encountered pathogens. This remarkable feature is what makes vaccines so effective in preventing diseases.
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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Related Experiment Video

Updated: Mar 9, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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[Immunogenicity of biosimilars].

L A G J M van Aerts1, A A M Franken, H G M Leufkens

  • 1College ter Beoordeling van Geneesmiddelen, Utrecht.

Nederlands Tijdschrift Voor Geneeskunde
|December 22, 2016
PubMed
Summary

Biosimilar manufacturers must prove no relevant differences from reference products. Post-approval monitoring of biosimilars, including immunogenicity, is crucial for patient safety.

Area of Science:

  • Biopharmaceuticals
  • Drug Development
  • Regulatory Science

Background:

  • Complex recombinant protein drugs, including monoclonal antibodies and fusion proteins, are increasingly available as biosimilars.
  • Regulatory agencies like the EMA mandate extensive comparability exercises to ensure biosimilar quality, safety, and efficacy match reference products.
  • Immunogenicity is a critical factor requiring rigorous assessment for both biosimilar and reference products.

Purpose of the Study:

  • To examine the assessment process and decision-making by authorities regarding the biosimilarity of complex recombinant protein drugs.
  • To analyze specific case studies involving etanercept and infliximab biosimilars.
  • To highlight potential discrepancies in the evaluation of biosimilarity and the need for ongoing surveillance.

Main Methods:

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  • Review of regulatory guidelines (e.g., EMA) for biosimilar comparability.
  • Analysis of assessment data for etanercept and infliximab biosimilars.
  • Evaluation of authorities' opinions on biosimilarity and remaining uncertainties.

Main Results:

  • Demonstrated the process by which regulatory authorities assess biosimilarity data for complex biologics.
  • Highlighted that consensus on biosimilarity is not always reached before marketing authorization.
  • Identified specific challenges in evaluating immunogenicity and overall biosimilarity.

Conclusions:

  • Extensive comparability studies are essential for biosimilar approval.
  • Ongoing monitoring of biosimilars post-marketing authorization is vital, as emphasized by the Dutch Medicines Evaluation Board.
  • Ensuring biosimilarity, particularly regarding immunogenicity, requires continuous vigilance to maintain patient safety and therapeutic equivalence.