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
-
Preface
Current Pharmaceutical Biotechnology Histone Deacetylases: Anti-Angiogenic Targets in Cancer Therapy
Current Cancer Drug Targets Anti-Cancer Agent-Induced Nephrotoxicity
Anti-Cancer Agents in Medicinal Chemistry Recent Patents in Circulating Cell-Free Tumor DNA as Biomarker in Cancer
Recent Patents on Biomarkers STAT3 Regulation of Glioblastoma Pathogenesis
Current Molecular Medicine Patent Selections
Recent Patents on Biomarkers Targeting Epigenetics through Histone Deacetylase Inhibitors in Acute Lymphoblastic Leukemia
Current Cancer Drug Targets The TRAIL to Viral Pathogenesis: The Good, the Bad and the Ugly
Current Molecular Medicine Current Bioactive Azole-Containing Natural Products
Current Bioactive Compounds Induction of Apoptosis by Pierisin-6 in HPV Positive HeLa and HepG2 Cancer Cells is Mediated by the Caspase-3 Dependent Mitochondrial Pathway
Anti-Cancer Agents in Medicinal Chemistry Infrequent Infections in COPD
Current Respiratory Medicine Reviews Application of Nanotechnology in the Treatment and Diagnosis of Gastrointestinal Cancers: Review of Recent Patents
Recent Patents on Anti-Cancer Drug Discovery Hypericin Lights Up the Way for the Potential Treatment of Nasopharyngeal Cancer by Photodynamic Therapy
Current Clinical Pharmacology CT-707 Overcomes Resistance of Crizotinib through Activating PDPK1- AKT1 Pathway by Targeting FAK
Current Cancer Drug Targets subject Index To Volume 2
Current Molecular Medicine An Insight into Purine, Tyrosine and Tryptophan Derived Marine Antineoplastic Alkaloids
Anti-Cancer Agents in Medicinal Chemistry MicroRNA Gene Networks in Oncogenesis
Current Genomics Inhibition of Membrane Complement Inhibitor Expression (CD46, CD55, CD59) by siRNA Sensitizes Tumor Cells to Complement Attack In Vitro
Current Cancer Drug Targets RNA Interference-Mediated Validation of Survivin and Apollon/BRUCE as New Therapeutic Targets for Cancer Therapy
Current Topics in Medicinal Chemistry The Application of Fungal Beta-glucans for the Treatment of Colon Cancer
Anti-Cancer Agents in Medicinal Chemistry