Abstract
Antibody formation is an intended physiological reaction to a “non-self” protein intentionally triggered in the case of vaccines. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to systematically assess an unwanted immune response following the administration of a biological drug. In this article, we discuss key aspects of this guideline and its concept, with a particular focus on the impact of immunogenicity on benefit/risk estimation of a therapeutic protein.
Keywords: Immunogenicity, biotechnology derived proteins, benefit/risk, risk assessment, regulatory guideline
Current Drug Safety
Title: Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals
Volume: 5 Issue: 4
Author(s): Isabel C. Buttel, Katrin Voller and Christian K. Schneider
Affiliation:
Keywords: Immunogenicity, biotechnology derived proteins, benefit/risk, risk assessment, regulatory guideline
Abstract: Antibody formation is an intended physiological reaction to a “non-self” protein intentionally triggered in the case of vaccines. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to systematically assess an unwanted immune response following the administration of a biological drug. In this article, we discuss key aspects of this guideline and its concept, with a particular focus on the impact of immunogenicity on benefit/risk estimation of a therapeutic protein.
Export Options
About this article
Cite this article as:
Buttel C. Isabel, Voller Katrin and Schneider K. Christian, Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals, Current Drug Safety 2010; 5 (4) . https://dx.doi.org/10.2174/157488610792245993
DOI https://dx.doi.org/10.2174/157488610792245993 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Understanding the Structural Basis of ALDH-2 Inhibition by Molecular Docking
Medicinal Chemistry Glutamate and Mitochondria: Two Prominent Players in the Oxidative Stress-Induced Neurodegeneration
Current Alzheimer Research Diet-Induced Hyperhomocysteinemia Increases Amyloid-β Formation and Deposition in a Mouse Model of Alzheimers Disease
Current Alzheimer Research Intrahippocampal Transplantation of Undifferentiated Human Chorionic- Derived Mesenchymal Stem Cells Does Not Improve Learning and Memory in the Rat Model of Sporadic Alzheimer Disease
Current Stem Cell Research & Therapy The Impacts of Some Sedative Drugs on α -Glycosidase, Acetylcholinesterase and Butyrylcholinesterase Enzymes-potential Drugs for Some Metabolic Diseases
Letters in Drug Design & Discovery Binding Model of Capsaicin is Able to Reach the Peripheral Anionic Site of Acetylcholinesterase
Current Bioactive Compounds Neurovascular Mechanisms of Hypertension in Pregnancy
Current Neurovascular Research The Psychoactive Effects of Antidepressants and their Association with Suicidality
Current Drug Safety Financial Returns on R&D: Looking Back at History, Looking Forward to Adaptive Licensing
Reviews on Recent Clinical Trials Editorial (Thematic Issue: Mitochondrial Dysfunction and Its Relation to Translocator Protein, Oxidative Stress, mTOR Signaling, and Synaptic Protein)
Mini-Reviews in Medicinal Chemistry Novel Cytoprotective Mediator, Stable Gastric Pentadecapeptide BPC 157. Vascular Recruitment and Gastrointestinal Tract Healing
Current Pharmaceutical Design Finding Drug Targets Through Analysis of the Platelet Transcriptome
Current Pharmaceutical Design Matrix Metalloproteinases as Drug Targets in Acute Pulmonary Embolism
Current Drug Targets Comparative Effectiveness of Agmatine and Choline Treatment in Rats with Cognitive Impairment Induced by AlCl<sub>3</sub> and Forced Swim Stress
Current Clinical Pharmacology Targeting Tumors Using Estrogen Receptor Ligand Conjugates
Current Cancer Drug Targets Impact of Aging on the Angiogenic Potential of the Myocardium: Implications for Angiogenic Therapies with Emphasis on Sirtuin Agonists
Recent Patents on Cardiovascular Drug Discovery Targeting Hypertension: Superoxide Anions are Involved in Apelin-induced Long-term High Blood Pressure and Sympathetic Activity in the Paraventricular Nucleus
Current Neurovascular Research Nucleotide Binding Affects Intrinsic Dynamics and Structural Communication in Ras GTPases
Current Pharmaceutical Design Subject Index To Volume 1
Recent Patents on CNS Drug Discovery (Discontinued) TLR7/9 Antagonists as Therapeutics for Immune-Mediated Inflammatory Disorders
Inflammation & Allergy - Drug Targets (Discontinued)