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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

165
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...
165
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

123
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...
123
Bioequivalence: Overview01:16

Bioequivalence: Overview

1.6K
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,...
1.6K
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

137
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...
137
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

94
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...
94
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

129
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.
129

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Updated: Dec 18, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars in supportive care.

Emma Foreman1

  • 1Pharmacy Department, The Royal Marsden NHS Foundation Trust, London, UK.

Current Opinion in Oncology
|June 17, 2020
PubMed
Summary
This summary is machine-generated.

Biosimilar medicines, including epoetin-alfa, filgrastim, and infliximab, are safe and effective alternatives to reference biologics. Their implementation offers cost savings and improves patient access, though challenges remain.

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Area of Science:

  • Oncology
  • Pharmacology
  • Health Policy

Background:

  • Biosimilar medicines offer therapeutic alternatives to reference biologics.
  • Supportive care in cancer treatment relies on effective and safe supportive medications.
  • Implementing biosimilars involves navigating clinical practice and health system challenges.

Purpose of the Study:

  • To review recent publications on biosimilar use in cancer supportive care.
  • To analyze the benefits and challenges of integrating biosimilars into clinical practice.
  • To assess the safety and efficacy of biosimilar medicines.

Main Methods:

  • Systematic literature review of recent publications.
  • Meta-analysis of existing studies on biosimilar safety and efficacy.
  • Analysis of guidelines on biosimilar interchangeability and substitution.

Main Results:

  • Biosimilars of epoetin-alfa, filgrastim, and infliximab are equivalent in safety and efficacy to reference biologics.
  • New guidelines address biosimilar interchangeability and substitution.
  • Biosimilar introduction improves patient access and reduces healthcare costs.
  • Barriers to biosimilar adoption must be addressed to realize full benefits.

Conclusions:

  • Extensive data supports the tolerability and effectiveness of supportive care biosimilars.
  • Over a decade of European experience provides valuable insights for biosimilar implementation.
  • Lessons learned from supportive care biosimilars can facilitate the introduction of newer biosimilars in treatment settings.