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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

288
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...
288
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

168
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...
168
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

Bioequivalence studies: Biowaivers

291
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...
291
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

216
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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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

211
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.
211

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Updated: Feb 17, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars: From Extrapolation into Off Label Use.

Sizheng Zhao1,2, Jagdish R Nair2, Robert J Moots1,2

  • 1Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.

Current Pharmaceutical Design
|December 1, 2017
PubMed
Summary
This summary is machine-generated.

Biosimilars offer expanded access to biologic treatments for inflammatory conditions. While concerns exist regarding indication extrapolation, post-marketing surveillance is crucial for ensuring safety and efficacy.

Keywords:
Biosimilarankylosing spondylitis.anti-TNFextrapolationmonoclonal antibodyoff-labelrheumatoid arthritis

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Area of Science:

  • Immunology
  • Pharmacology
  • Biotechnology

Background:

  • Biologic drugs have transformed inflammatory condition management.
  • Patent expirations have led to the development of biosimilars, which are highly similar but non-identical molecules.
  • Extrapolation of indications is a key concept in biosimilar development, but raises concerns about efficacy and immunogenicity.

Purpose of the Study:

  • To revisit the concepts of biosimilarity and extrapolation of indications.
  • To examine concerns surrounding extrapolation using biosimilar infliximab (CT-P13) as an example.
  • To review the opportunities and cautions for using biologics and biosimilars in unlicensed inflammatory conditions.

Main Methods:

  • A narrative overview based on literature search and author experience.
  • Literature search conducted using PubMed, Web of Science, and regulatory agency archives (FDA, EMA).

Main Results:

  • Concerns regarding biosimilar extrapolation were analyzed concerning mechanisms of action, immunogenicity, and clinical trial design.
  • The review explored the potential for biosimilars to improve access to treatments for rare inflammatory conditions and for off-label use.

Conclusions:

  • Biosimilars present opportunities to enhance treatment access and options, particularly for rare diseases and off-label applications.
  • Balancing the benefits of biosimilars with the risks of off-label prescribing is essential.
  • Robust post-marketing surveillance is critical for establishing long-term evidence of biosimilar efficacy and safety.