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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body: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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Bioequivalence: Overview01:16

Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Equivalence: In Vitro and In Vivo Bioequivalence01:17

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Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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Body: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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Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

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Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
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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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From Basic Immunology to Clinical Practice: Bio-Originators versus Bio-Similars.

Stamatis-Nick C Liossis1,2, Georgia M Konstantopoulou1

  • 1Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, Rion, Patras, Greece.

Mediterranean Journal of Rheumatology
|June 12, 2020
PubMed
Summary
This summary is machine-generated.

Biosimilars offer a more accessible alternative to expensive biologic agents. Rigorous comparative studies ensure their quality, efficacy, and safety mirror the original biologic products.

Keywords:
Bio-Originatorsbiosimilarsimmunogenicitypharmacovigilance

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Area of Science:

  • Biopharmaceutical science
  • Immunology
  • Drug development

Background:

  • Biologic agents are complex macromolecules with inherent structural heterogeneity.
  • High treatment costs limit patient access to originator biologic therapies.
  • Biosimilars are developed to be highly similar to existing biologic agents, increasing accessibility.

Purpose of the Study:

  • To outline the comprehensive requirements for biosimilar development and characterization.
  • To emphasize the importance of comparing immunological properties between biosimilars and originators.
  • To ensure biosimilars meet rigorous standards for quality, efficacy, and safety.

Main Methods:

  • Comprehensive qualitative documentation review.
  • Preclinical pharmacodynamic and pharmacokinetic studies.
  • Comparative analytical, preclinical, and clinical studies against the originator biologic.

Main Results:

  • Demonstration of high similarity in quality characteristics, biological activity, efficacy, and safety.
  • Characterization of immunological properties to ensure comparability.
  • Ongoing immunogenicity assessment throughout clinical trials and pharmacovigilance.

Conclusions:

  • Biosimilar development requires extensive comparative data to establish similarity to originator biologics.
  • Rigorous assessment ensures biosimilars provide comparable therapeutic outcomes and safety profiles.
  • Post-market surveillance is crucial for continued immunogenicity monitoring.