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
-
The Role of Diffusion-weighted Imaging in Patients with Gastric Wall Thickening
Current Medical Imaging Breast Cancer, a Stem Cell Disease
Current Stem Cell Research & Therapy Radionuclide Therapy of Cancer with Radiolabeled Antibodies
Anti-Cancer Agents in Medicinal Chemistry Current Advances in the Development of Anticancer Drugs Targeting Tyrosine Kinases of the Src Family
Current Drug Therapy Enhancing the Cytotoxic Activity of Novel Targeted Therapies – Is There a Role for a Combinatorial Approach?
Current Clinical Pharmacology Epigenetic Regulation of Cytochrome P450 Enzymes and Clinical Implication
Current Drug Metabolism Glyco-Engineering of Human IgG-Fc to Modulate Biologic Activities
Current Pharmaceutical Biotechnology STAT-3 Inhibitors: State of the Art and New Horizons for Cancer Treatment
Current Medicinal Chemistry Meet Our Editorial Board Member
Current Bioinformatics Recent Development in Indole Derivatives as Anticancer Agent: A Mechanistic Approach
Anti-Cancer Agents in Medicinal Chemistry Physcion and Physcion 8-O-β-D-glucopyranoside: Natural Anthraquinones with Potential Anticancer Activities
Current Drug Targets Synthesis, <i>In Vitro</i> Evaluation, Molecular Docking and DFT Studies of Some Phenyl Isothiocyanates as Anticancer Agents
Anti-Cancer Agents in Medicinal Chemistry Recent Progress in the Development of Histone Deacetylase Inhibitors as Anti-Cancer Agents
Mini-Reviews in Medicinal Chemistry Immunological Aspects of Adult T-Cell Leukemia/Lymphoma (ATLL), a Possible Neoplasm of Regulatory T-Cells
Current Immunology Reviews (Discontinued) Inhibiting the “Undruggable” RAS/Farnesyltransferase (FTase) Cancer Target by Manumycin-related Natural Products
Current Medicinal Chemistry Evolving Strategies for the Treatment of T-Cell Lymphoma: A Systematic Review and Recent Patents
Recent Patents on Anti-Cancer Drug Discovery Recent Patents Relating to Tumor Suppressor Genes
Recent Patents on DNA & Gene Sequences Rasburicase: A New Approach for Preventing and/or Treating Tumor Lysis Syndrome
Current Pharmaceutical Design Targeting Oncogenes and Tumor Suppressors genes to Mitigate Chemoresistance
Current Cancer Drug Targets Tyrosine Kinases as Therapeutic Targets in BCR-ABL Negative Chronic Myeloproliferative Disorders
Current Drug Targets