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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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Related Experiment Video

Updated: Mar 24, 2026

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

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

Anti-TNFs: Originators and Biosimilars.

Gerassimos J Mantzaris¹

¹Department of Gastroenterology, 'Evangelismos' Hospital, Athens, Greece.

Digestive Diseases (Basel, Switzerland)

|March 17, 2016

Summary

Biosimilar (BS) anti-tumor necrosis factor alpha (TNFα) biologics offer lower-cost alternatives for inflammatory bowel disease (IBD) treatment. Regulatory approval and physician confidence are key to their widespread adoption and market integration.

Area of Science:

Gastroenterology
Pharmacology
Biotechnology

Background:

Anti-tumor necrosis factor alpha (TNFα) biologics have transformed inflammatory bowel disease (IBD) treatment but are costly.
Patent expirations have led to the development of biosimilar (BS) versions of originator biologics (ORGs).

Purpose of the Study:

To discuss the development, regulatory approval, and implications of biosimilar anti-TNFα therapies for IBD.
To address the scientific and legal considerations surrounding biosimilar extrapolation and interchangeability.

Main Methods:

Comprehensive comparability studies, including in vitro tests, models, and clinical conditions, are required to demonstrate biosimilarity.
Regulatory frameworks for biosimilar approval, extrapolation of indications, and interchangeability vary globally.

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Published on: May 4, 2017

A Three-dimensional Thymic Culture System to Generate Murine Induced Pluripotent Stem Cell-derived Tumor Antigen-specific Thymic Emigrants

A Three-dimensional Thymic Culture System to Generate Murine Induced Pluripotent Stem Cell-derived Tumor Antigen-specific Thymic Emigrants

Published on: August 9, 2019

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Last Updated: Mar 24, 2026

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

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

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

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

Published on: May 4, 2017

A Three-dimensional Thymic Culture System to Generate Murine Induced Pluripotent Stem Cell-derived Tumor Antigen-specific Thymic Emigrants

A Three-dimensional Thymic Culture System to Generate Murine Induced Pluripotent Stem Cell-derived Tumor Antigen-specific Thymic Emigrants

Published on: August 9, 2019

Main Results:

Marketing authorization of infliximab biosimilars (CT-P13) by some agencies has generated debate regarding scientific adequacy.
Extrapolation of indications and automatic substitution are contentious issues within the IBD community.

Conclusions:

Post-marketing surveillance, pharmacovigilance, traceability, registries, and further studies are crucial for building physician and patient confidence in biosimilars.
A globally harmonized legal framework is needed as more non-anti-TNFα biosimilars enter the market.