Related Experiment Video
Updated: Jun 21, 2026
07:25
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
The challenges of immunogenicity in developing biosimilar products
1National Institute for Biological Standards and Control, Hertfordshire, UK.
Idrugs : the Investigational Drugs Journal
|July 7, 2009
Summary
Unwanted immunogenicity in biotherapeutics, including subsequent entry biologics (SEBs), poses risks. This article reviews challenges in predicting and assessing SEB immunogenicity and discusses current guidance for biotherapeutic products.
Area of Science:
- Biotechnology
- Immunology
- Pharmacology
Background:
- Unwanted immunogenicity is a major concern for biotherapeutic products.
- Immunogenicity can lead to adverse reactions and reduced treatment efficacy.
- Subsequent entry biological (SEB) medicines are particularly affected.
Purpose of the Study:
- To provide an overview of challenges in predicting and assessing SEB immunogenicity.
- To discuss available guidance on assessing the immunogenicity of biotherapeutic products.
- To highlight issues relevant to biosimilar product development.
Main Methods:
- Literature review of immunogenicity assessment strategies.
- Analysis of industry challenges in biotherapeutic development.
- Discussion of regulatory guidance for biosimilars.
Main Results:
- Significant challenges exist in predicting and assessing the immunogenicity of SEBs.
- Current guidance for biotherapeutic immunogenicity assessment is available but requires careful application to SEBs.
- The development of biosimilar products faces specific immunogenicity hurdles.
Conclusions:
- Addressing immunogenicity prediction and assessment is crucial for SEB safety and efficacy.
- Clearer guidance and improved methodologies are needed for biosimilar immunogenicity evaluation.
- Industry and regulatory collaboration is essential to overcome these challenges.
Related Concept Videos
01:28Drug Products: Biologics, Biosimilars and Interchangeables
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...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
01:26Antigens Involved in Adaptive Immunity
An antigen is any substance the immune system identifies as foreign and potentially harmful to the body, prompting an immune response. Antigens have two functional properties: immunogenicity and reactivity. Immunogenicity is the ability of an antigen to stimulate a specific immune response. At the same time, reactivity describes the antigen's ability to react with the cells and antibodies produced in response to it.
Complete Antigens
Complete antigens possess both immunogenicity and reactivity.
Complete Antigens
Complete antigens possess both immunogenicity and reactivity.
01:16Bioequivalence: Overview
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,...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...