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Related Experiment Videos

Analytic characterization of biosimilars.

Peter M Sullivan1, Lisa M DiGrazia2

  • 1Amneal Biosciences, LLC, Bridgewater, NJ. psullivan@amneal.com.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|April 9, 2017
PubMed
Summary

Biosimilar development requires rigorous analytical characterization to ensure high similarity to the reference product. Healthcare providers must understand these requirements for biosimilar approval and patient safety.

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Area of Science:

  • Biopharmaceutical Development
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Biosimilars offer therapeutic alternatives to reference biologics.
  • Understanding the biosimilar development pathway is crucial for healthcare providers.
  • Analytical characterization forms the cornerstone of biosimilar comparability.

Purpose of the Study:

  • To describe the biosimilar development process.
  • To outline comparability requirements for biological agents.
  • To detail the analytical characterization of biosimilars.

Main Methods:

  • Extensive analytical techniques are employed to characterize biosimilar candidates.
  • Nonclinical studies include toxicology and immunogenicity assessments in animals.
Keywords:
analytic characterization testingbiosimilar pharmaceuticalscomparabilitycritical quality attributeshighly similarreference product

Related Experiment Videos

  • Clinical pharmacology studies evaluate safety, pharmacokinetics, and pharmacodynamics in humans.

    • Main Results:

    • Analytical characterization confirms high similarity between biosimilar and reference products.
    • Advanced techniques identify potential molecular and functional differences.
    • Testing includes primary and higher-order structure, posttranslational modifications, binding, and potency.

    Conclusions:

    • Biosimilar approval hinges on comprehensive analytical characterization and totality of evidence.
    • Understanding biosimilar science ensures product purity, safety, and efficacy.
    • Additional clinical studies may be required if residual uncertainty exists.