Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

219
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...
219
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

357
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...
357
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

782
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
782
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

410
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...
410
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.3K
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,...
2.3K
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

343
The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
343

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Personalized infliximab rescue therapy to maximize colectomy-free survival in patients with acute severe ulcerative colitis.

Journal of Crohn's & colitis·2026
Same author

Pharmacokinetics and Exposure-Response During Infliximab Induction Therapy in Pediatric IBD Using Point-of-Care Assay.

Journal of clinical medicine·2025
Same author

Spatial transcriptomics reveals unique inflammatory signatures across all anatomic locations in postoperative Crohn's disease.

Journal of Crohn's & colitis·2025
Same author

Metabolism and response to stress gene signatures reveal ulcerative colitis heterogeneity and identify patients with increased response to therapy.

Journal of Crohn's & colitis·2025
Same author

Expert recommendations to standardize transcriptomic analysis in inflammatory bowel disease clinical trials.

Journal of Crohn's & colitis·2025
Same author

Predictive Model for Outcomes in Inflammatory Bowel Disease Patients Receiving Maintenance Infliximab Therapy.

Crohn's & colitis 360·2024

Related Experiment Video

Updated: Apr 10, 2026

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
16:07

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

9.7K

IBD: Indication extrapolation for anti-TNF biosimilars.

Niels Vande Casteele1, William J Sandborn1

  • 1Division of Gastroenterology, University of California San Diego, 9500 Gilman Drive, MC 0956, La Jolla, CA 92093-0956, USA.

Nature Reviews. Gastroenterology & Hepatology
|June 17, 2015
PubMed
Summary

Biosimilar monoclonal antibodies (mAbs) targeting TNF are emerging, with CT-P13 being the first approved infliximab biosimilar. Key questions persist regarding its use across different conditions and its interchangeability with the original drug.

More Related Videos

Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method
14:48

Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method

Published on: July 6, 2012

44.4K
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.3K

Related Experiment Videos

Last Updated: Apr 10, 2026

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
16:07

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

9.7K
Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method
14:48

Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method

Published on: July 6, 2012

44.4K
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.3K

Area of Science:

  • Immunology
  • Biotechnology
  • Pharmacology

Background:

  • Development of biosimilar monoclonal antibodies (mAbs) targeting Tumor Necrosis Factor (TNF) is advancing.
  • These biosimilars are designed to be highly similar, though not identical, to innovator biologic drugs.
  • CT-P13 represents the first anti-TNF mAb biosimilar to receive regulatory approval in multiple major markets.

Discussion:

  • The approval of CT-P13 in South Korea, Europe, and Canada marks a significant milestone in biosimilar development.
  • Despite regulatory successes, clinical and regulatory uncertainties regarding indication extrapolation remain.
  • The interchangeability of CT-P13 with the reference infliximab product is also an area requiring further clarification.

Key Insights:

  • CT-P13 is the pioneering biosimilar of infliximab, an anti-TNF monoclonal antibody.
  • Regulatory approvals have been secured in key regions including South Korea, Europe, and Canada.
  • Significant questions persist concerning the extrapolation of indications and the interchangeability of CT-P13.

Outlook:

  • Further clinical studies and regulatory assessments are needed to address uncertainties surrounding indication extrapolation.
  • Establishing the interchangeability of CT-P13 will be crucial for its widespread clinical adoption and patient access.
  • The success of CT-P13 may pave the way for other anti-TNF biosimilar approvals and broader biosimilar market penetration.