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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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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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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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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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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: 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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilar medicines - Review.

Camila Dos Reis1, Ricardo Teixo2, Fernando Mendes2,3,4

  • 1Polytechnic Institute of Coimbra, ESTESC-Coimbra Health School, Department of Pharmacy, Coimbra, Portugal.

The International Journal of Risk & Safety in Medicine
|May 14, 2016
PubMed
Summary
This summary is machine-generated.

Biosimilars demonstrate clinical efficacy and safety comparable to reference biologics, offering reduced costs and increased treatment access. Further research is needed on immunogenicity and interchangeability.

Keywords:
Biosimilarsbiologicsefficacyextrapolationimmunogenicityinterchangeabilitysafety

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Area of Science:

  • Pharmacology
  • Biotechnology
  • Drug Development

Background:

  • Biosimilars are highly similar to approved biologic reference drugs.
  • Their development aims to reduce healthcare costs and improve patient access to treatments.
  • Concerns exist regarding quality, effectiveness, and safety despite cost reductions.

Purpose of the Study:

  • To evaluate the similarity between biosimilars and their reference biopharmaceuticals.
  • To understand the impact of production processes and approval requirements on biosimilar quality, safety, efficacy, and cost.
  • To assess the overall value proposition of biosimilars in healthcare.

Main Methods:

  • A systematic review of literature was conducted.
  • Searches were performed in b-on, PubMed, and Medscape databases from 2005 to 2014.
  • 23 relevant articles were selected for analysis.

Main Results:

  • Biosimilars and reference biologics show no significant differences in clinical efficacy and safety.
  • Comparability tests confirm similarity, with variations mainly due to manufacturing processes.
  • These findings support the viability of biosimilars as therapeutic alternatives.

Conclusions:

  • Biosimilars represent a significant advancement in therapeutic options and targeted therapies.
  • Ongoing research and debate are crucial for addressing issues like immunogenicity, interchangeability, automatic substitution, and extrapolation of indications.
  • The future will see increased utilization of biosimilars, necessitating continued scientific and regulatory scrutiny.