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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

1.9K
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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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 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...
253
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

224
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.
224
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

211
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...
211
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

158
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...
158

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From bioequivalence to biosimilars: How much do regulators dare?

Martina Weise1

  • 1Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM),Bonn, Germany.

Zeitschrift Fur Evidenz, Fortbildung Und Qualitat Im Gesundheitswesen
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Summary

Biosimilars, highly similar to reference biologics, utilize abbreviated licensing pathways. Extensive comparative data ensures their safety and efficacy, with over a decade of successful use in the EU.

Keywords:
BiosimilarsBioäquivalenzExtrapolationGenerikaVergleichbarkeitsstudienbioequivalencebiosimilarscomparability exerciseextrapolationgenerics

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Area of Science:

  • Biopharmaceuticals
  • Drug Development
  • Regulatory Science

Background:

  • Abbreviated licensing pathways reduce clinical development for generics and biosimilars.
  • Concerns exist regarding biosimilar efficacy and safety, particularly in extrapolated indications.
  • Biologicals are complex and inherently variable, making exact replication impossible; biosimilars are 'highly similar,' not identical, to reference products.

Purpose of the Study:

  • To explain the scientific rationale behind abbreviated approval pathways for biosimilars.
  • To address clinician and patient concerns about biosimilar extrapolation.
  • To highlight the rigorous data requirements for biosimilar approval compared to generics.

Main Methods:

  • Comparative analysis of regulatory requirements for generics and biosimilars.
  • Review of scientific principles governing biosimilar development and approval.
  • Examination of clinical experience with biosimilars in the European Union.

Main Results:

  • Biosimilar approval requires comprehensive physicochemical, biological, functional, efficacy, safety, and immunogenicity data compared to reference products.
  • Extrapolation to new indications for biosimilars demands robust scientific justification.
  • Over 10 years of EU experience demonstrates the safety and efficacy of approved biosimilars without product withdrawals or labeling changes due to safety concerns.

Conclusions:

  • The 'highly similar' paradigm for biosimilars is scientifically sound, despite potential confusion.
  • Abbreviated pathways for biosimilars are based on rigorous comparative data, ensuring safety and efficacy.
  • Extensive clinical use validates the biosimilar regulatory concept and its application.