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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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

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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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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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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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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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A 'Global Reference' Comparator for Biosimilar Development.

Christopher J Webster1, Gillian R Woollett2

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Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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Summary
This summary is machine-generated.

Biosimilar development can be streamlined by using globally licensed reference biologics, avoiding costly bridging studies. This simplifies regulatory pathways for biosimilar approval worldwide.

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Area of Science:

  • Biopharmaceutical development
  • Regulatory science
  • Comparative analytics

Background:

  • Drug regulators permit using biosimilar development data from foreign-licensed reference products.
  • Most authorities mandate bridging studies comparing foreign and local reference product versions.
  • These repetitive bridging studies incur substantial costs for biosimilar sponsors.

Purpose of the Study:

  • To propose a simplified approach for selecting reference comparators for biosimilar development.
  • To eliminate the need for new bridging studies by leveraging existing data.
  • To discuss the implications for biosimilar approval and interchangeability designations.

Main Methods:

  • Analyzing shared development data across different jurisdictional versions of reference biologics.
  • Reviewing comparability assessments for manufacturing changes between reference product versions.
  • Examining successful biosimilar approvals in multiple regions as evidence.

Main Results:

  • Minor analytical differences between reference biologic versions are typically clinically insignificant.
  • Shared development data and rigorous comparability processes support a unified approach.
  • Existing biosimilar approvals demonstrate the feasibility of using diverse reference product versions.

Conclusions:

  • A simplified basis for reference comparator selection, negating bridging studies, is proposed.
  • This approach reduces development costs and timelines for biosimilars.
  • The proposal has significant implications for global biosimilar market access and interchangeability.