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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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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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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Bioequivalence studies: Biowaivers01:13

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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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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Biopharmaceutics and Pharmacokinetics: Overview01:28

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Demonstrating Value for Biosimilars: A Conceptual Framework.

Sotiris Rompas1, Thomas Goss2, Sally Amanuel3

  • 1Director, Boston Healthcare Associates, MA.

American Health & Drug Benefits
|June 19, 2015
PubMed
Summary
This summary is machine-generated.

Biosimilar value extends beyond cost savings, requiring a framework that addresses diverse stakeholder needs. Understanding these needs is crucial for successful development, commercialization, and adoption of biosimilars.

Keywords:
biologicsbiosimilar adoptionbiosimilarscommercializationdrug developmentgeneric drugspatientspayersprovidersreference drugregulatory guidancevalue proposition

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Area of Science:

  • Pharmacoeconomics
  • Health Services Research
  • Drug Development

Background:

  • Biosimilar value proposition extends beyond cost reduction to encompass diverse stakeholder needs.
  • Successful transition from clinical development to market requires a comprehensive framework.

Purpose of the Study:

  • Identify factors influencing biosimilar development, commercialization, and adoption.
  • Recommend program design modifications to demonstrate biosimilar value to payers, providers, and patients.

Main Methods:

  • Surveys with payers and clinicians in the US and EU5 markets.
  • International protocol feasibility assessments.
  • Literature review on patient perceptions of generics to inform biosimilar hypotheses.

Main Results:

  • Conflicting and convergent demands exist for biosimilar data collection.
  • Motivations and data requirements vary among stakeholders.
  • Regulatory, economic, and clinical incentives need careful consideration.

Conclusions:

  • Biosimilar development is an international endeavor with potential challenges and opportunities.
  • Evolving regulatory guidance and stakeholder sentiments shape development and positioning.
  • Program design must align with payer, physician, and patient needs for successful market entry.