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 |
- 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
-
Transient Hepatotoxicity Induced by Vinblastine in a Young Girl with Chiasmatic Low Grade Glioma
Current Drug Safety Aluminofluoride Complexes: Phosphate Analogues and a Hidden Hazard for Living Organisms
Current Inorganic Chemistry (Discontinued) B Cell Depletion with Rituximab in Graves Disease and Associated Orbitopathy
Immunology, Endocrine & Metabolic Agents in Medicinal Chemistry (Discontinued) Green Synthesis of Silver Nanocomposites of Nigella sativa Seeds Extract for Hepatocellular Carcinoma
Current Nanomaterials Pharmacogenetics of Asthma Therapy
Current Pharmaceutical Design Sumoylation in Cellular Senescence and Aging
Current Molecular Medicine Functional Analyses of the Human Genome Based on Large-Scale Fulllength cDNA Resources
Current Genomics Oxidative Stress and Post-Stroke Depression: Possible Therapeutic Role of Polyphenols?
Current Medicinal Chemistry Editorial [Hot Topic: Targeting Tumor Uniquitin-Proteasome Pathway with New and Old Drugs (Guest Editor: Q. Ping Dou)]
Current Cancer Drug Targets Identification of Novel Drug Targets in HpB38, HpP12, HpG27, Hpshi470, HpSJM180 Strains of Helicobacter pylori : An In Silico Approach for Therapeutic Intervention
Current Drug Targets Transposon-Based Engineering of Clinical-Grade T Cells for Cancer Therapy
Current Drug Therapy Thiazolidinedione: A Privileged Scaffold for the Development of Anticancer Agents
Current Topics in Medicinal Chemistry Anti-Inflammatory Agents in Ageing and Age-Associated Diseases
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry Mitochondria in Cancer Stem Cells: A Target for Therapy
Recent Patents on Endocrine, Metabolic & Immune Drug Discovery (Discontinued) Targeted Drug Delivery System for Platinum-based Anticancer Drugs
Mini-Reviews in Medicinal Chemistry Opioid Free Anaesthesia and Cancer
Current Pharmaceutical Design Breast Cancer: Current Developments in Molecular Approaches to Diagnosis and Treatment
Recent Patents on Anti-Cancer Drug Discovery Hematopoietic Stem Cell Transplantation for Thalassemia
Current Stem Cell Research & Therapy TNF-Alpha Antagonism in Severe Asthma?
Recent Patents on Inflammation & Allergy Drug Discovery Reducing False Positive Findings in Statistical Analysis of Pharmacogenomic Biomarker Studies Using High-Throughput Technologies
Current Drug Safety