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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

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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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Pharmaceutical Equivalents01:26

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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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

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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars: how similar?

V Strand1, B Cronstein

  • 1Biopharmaceutical Consultant, Portola Valley, California, USA.

Internal Medicine Journal
|October 15, 2013
PubMed
Summary
This summary is machine-generated.

Biosimilars offer a promising avenue for more affordable biologic treatments for rheumatic diseases as patents expire. Their development and approval, however, present unique challenges for pharmaceutical companies and regulatory bodies.

Keywords:
biosimilarbiosimilar regulationintended copymonoclonal antibody

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Area of Science:

  • Rheumatology
  • Pharmacology
  • Regulatory Science

Background:

  • Patent expirations for biologic agents create opportunities for developing non-proprietary alternatives.
  • Biosimilars promise high-quality, lower-cost biologic treatments for rheumatic diseases.
  • The emergence of biosimilars introduces new complexities in drug development and market access.

Purpose of the Study:

  • To review the definitions and characteristics of biosimilars.
  • To examine the regulatory hurdles associated with biosimilar approval.
  • To provide an overview of the current landscape of approved biosimilars.

Main Methods:

  • Literature review of biosimilar definitions and regulatory pathways.
  • Analysis of regulatory agency guidelines for biosimilar development.
  • Compilation and review of publicly available data on approved biosimilars.

Main Results:

  • Established definitions and key attributes of biosimilar agents.
  • Identified significant regulatory challenges in the approval process for biosimilars.
  • Summarized the historical record of biosimilar approvals in relevant markets.

Conclusions:

  • Biosimilars represent a significant advancement in making biologic therapies more accessible.
  • Navigating regulatory pathways remains a critical factor for successful biosimilar development and market entry.
  • The growing number of approvals indicates increasing acceptance and viability of biosimilars in treating rheumatic conditions.