Abstract
Monoclonal antibodies (mAbs) comprise the majority of protein candidates currently in clinical development because of their versatility as therapeutic agents. While traditionally associated with the biotechnology industry, mAb therapeutics are now being developed and marketed by most major pharmaceutical firms. A total of 21 products are approved in the US, with additional products marketed outside the US, and over 200 mAb candidates are currently undergoing clinical study. Benchmark data for mAb therapeutics, such as clinical development and US Food and Drug Administration approval times, approval success rates, and clinical phase transition probabilities, are critical for strategic planning purposes. Trends in these benchmarks for various types of mAbs, with an emphasis on those studied as anticancer and immunological therapeutics, are discussed.
Keywords: Monoclonal antibodies, success rates, clinical study, Food and Drug Administration, marketing approval, benchmarks
Current Pharmaceutical Biotechnology
Title: Monoclonal Antibodies as Innovative Therapeutics
Volume: 9 Issue: 6
Author(s): Janice M. Reichert
Affiliation:
Keywords: Monoclonal antibodies, success rates, clinical study, Food and Drug Administration, marketing approval, benchmarks
Abstract: Monoclonal antibodies (mAbs) comprise the majority of protein candidates currently in clinical development because of their versatility as therapeutic agents. While traditionally associated with the biotechnology industry, mAb therapeutics are now being developed and marketed by most major pharmaceutical firms. A total of 21 products are approved in the US, with additional products marketed outside the US, and over 200 mAb candidates are currently undergoing clinical study. Benchmark data for mAb therapeutics, such as clinical development and US Food and Drug Administration approval times, approval success rates, and clinical phase transition probabilities, are critical for strategic planning purposes. Trends in these benchmarks for various types of mAbs, with an emphasis on those studied as anticancer and immunological therapeutics, are discussed.
Export Options
About this article
Cite this article as:
Reichert M. Janice, Monoclonal Antibodies as Innovative Therapeutics, Current Pharmaceutical Biotechnology 2008; 9 (6) . https://dx.doi.org/10.2174/138920108786786358
DOI https://dx.doi.org/10.2174/138920108786786358 |
Print ISSN 1389-2010 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4316 |
Call for Papers in Thematic Issues
Artificial Intelligence in Bioinformatics
Bioinformatics is an interdisciplinary field that analyzes and explores biological data. This field combines biology and information system. Artificial Intelligence (AI) has attracted great attention as it tries to replicate human intelligence. It has become common technology for analyzing and solving complex data and problems and encompasses sub-fields of machine ...read more
- 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
-
Immunotherapy in Liver Diseases: A Balance Between Immunity and Tolerance
Current Drug Metabolism Class II Phosphoinositide 3-Kinases as Potential Novel Drug Targets
Current Signal Transduction Therapy Histone Methylation and microRNA-dependent Regulation of Epigenetic Activities in Neural Progenitor Self-Renewal and Differentiation
Current Topics in Medicinal Chemistry Advances on Semisynthesis, Total Synthesis, and Structure-Activity Relationships of Honokiol and Magnolol Derivatives
Mini-Reviews in Medicinal Chemistry Inhibitors of the PI3K/Akt/mTOR Pathway: New Hope for Breast Cancer Patients
Recent Patents on Anti-Cancer Drug Discovery Excessive Oxidative Stress in the Synergistic Effects of Shikonin on the Hyperthermia-Induced Apoptosis
Current Molecular Medicine Cell Cycle and Energy Metabolism in Tumor Cells: Strategies for Drug Therapy
Recent Patents on Anti-Cancer Drug Discovery Graphical Abstracts:
Current Organic Chemistry n-3 Polyunsaturated Fatty Acids and the Prevention of Colorectal Cancer: Molecular Mechanisms Involved
Current Medicinal Chemistry Bone Marrow Aspiration/Biopsy in the Evaluation of Fever of Unknown Origin in Patients with AIDS
Infectious Disorders - Drug Targets Dysregulated NF-κB Pathway in Peripheral Mononuclear Cells of Alzheimers Disease Patients
Current Alzheimer Research Thiopurines in Inflammatory Bowel Disease - The Role of Pharmacogenetics and Therapeutic Drug Monitoring
Current Pharmacogenomics PEGylated Peptide-Based Imaging Agents for Targeted Molecular Imaging
Current Protein & Peptide Science Distinctive Cellular Roles for Novel Protein Kinase C Isoenzymes
Current Pharmaceutical Design Gene Therapy Approaches in an Autoimmune Demyelinating Disease: Multiple Sclerosis
Current Gene Therapy Polysulfated/Sulfonated Compounds for the Development of Drugs at the Crossroad of Viral Infection and Oncogenesis
Current Pharmaceutical Design Bestatin as an Experimental Tool in Mammals
Current Drug Metabolism “Endothelial Progenitor Cells” as a Therapeutic Strategy in Cardiovascular Disease
Current Vascular Pharmacology Fluorinated Molecules as Drugs and Imaging Agents in the CNS
Current Topics in Medicinal Chemistry EGFR Intron Recombination in Human Gliomas: Inappropriate Diversion of V(D)J Recombination?
Current Genomics