An overview of FDA-approved biologics medicines

Drug Discovery Today

Volumn 20, Issue 4, 2015, Pages 393-398

  Kinch, Michael S ^a  

^a WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABCIXIMAB; ALPHA2A INTERFERON; ALTEPLASE; ASPARAGINASE MACROGOL; BASILIXIMAB; BIOLOGICAL PRODUCT; DORNASE ALFA; FILGRASTIM; HUMAN INSULIN; IMIGLUCERASE; OKT 3; PALIVIZUMAB; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT HUMAN INSULIN; RETEPLASE; RITUXIMAB; SAGRAMOSTIM; UNCLASSIFIED DRUG; CELL RECEPTOR; CELL SURFACE RECEPTOR; ENZYME; MONOCLONAL ANTIBODY;

ARTICLE; BIOTECHNOLOGY; DNA VECTOR; DRUG ACTIVITY; DRUG APPROVAL; DRUG INDUSTRY; DRUG TARGETING; ENZYME REPLACEMENT; FOOD AND DRUG ADMINISTRATION; IMMUNOGENICITY; RECOMBINANT DNA TECHNOLOGY; ANIMAL; DRUG EFFECTS; HUMAN; PATIENT SAFETY; RISK ASSESSMENT; RISK FACTOR; TREATMENT OUTCOME; UNITED STATES;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL PRODUCTS; DRUG APPROVAL; ENZYMES; HUMANS; PATIENT SAFETY; RECEPTORS, CELL SURFACE; RECEPTORS, CYTOPLASMIC AND NUCLEAR; RISK ASSESSMENT; RISK FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84928713530     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2014.09.003     Document Type: Short Survey

References (25)

1. D.A. Jackson Biochemical method for inserting new genetic information into DNA of Simian Virus 40: circular SV40 DNA molecules containing lambda phage genes and the galactose operon of Escherichia coli Proc. Natl. Acad. Sci. U. S. A. 69 1972 2904 2909
2. S.N. Cohen, and A.C.Y. Chang Recircularization and autonomous replication of a sheared R-factor DNA segment in Escherichia coli transformants Proc. Natl. Acad. Sci. U. S. A. 70 1973 1293 1297
3. P. Berg, and M.F. Singer The recombinant DNA controversy: twenty years later Proc. Natl. Acad. Sci. U. S. A. 92 1995 9011
4. P. Berg Summary statement of the Asilomar conference on recombinant DNA molecules Proc. Natl. Acad. Sci. U. S. A. 72 1975 1981
5. S.S. Hughes Genentech: The Beginnings of Biotech 2011 University of Chicago Press
6. E. Russo Special Report: the birth of biotechnology Nature 421 2003 456 457
7. M.S. Kinch An overview of FDA-approved new molecular entities: 1827-2013 Drug Discov. Today 19 2014 1033 1039
8. J.M. Reichert Background: Monoclonal Antibody Therapeutics 2014 Landes Bioscience
9. G. Goldstein Overview of the development of Orthoclone OKT3: monoclonal antibody for therapeutic use in transplantation Transpl. Proc. 19 1987 1 6
10. P.T. Jones Replacing the complementarity-determining regions in a human antibody with those from a mouse Nature 321 1986 522 525
11. H. Wu Balancing a biologics pipeline portfolio Drug Discov. World Spring 2011 2011 77 80
12. R.P. Evens, and K.I. Kaitin The Biotechnology Innovation Machine: a source of intelligent biopharmaceuticals for the pharma industry - mapping biotechnology's success Clin. Pharmacol. Ther. 95 2014 528 532
13. O. Wellman-Labadie, and Y. Zhou The US Orphan Drug Act: rare disease research stimulator or commercial opportunity? Health Policy 95 2010 216 228
14. M.S. Kinch Trends in pharmaceutical targeting of clinical indications: 1930-2013 Drug Discov. Today 2014 10.1016/j.drudis.2014.05.021
15. M.S. Kinch The rise (and decline?) of biotechnology Drug Discov. Today 2014 10.1016/j.drudis.2014.04.006
16. S.P. Lovinger Use of biologics for rheumatoid arthritis tempered by concerns over safety, cost JAMA 289 2003 3229 3230
17. S.S. Farid Process economics of industrial monoclonal antibody manufacture J. Chromatogr. B 848 2007 8 18
18. P.R.J. Ansell Hybridoma technology: a view from the patent arena Immunol. Today 21 2000 357 358
19. S. Trüssel Half-life extension by binding to albumin through small molecules R. Kontermann, Therapeutic Proteins 2012 Wiley-VCH Verlag 285 296
20. S.D. Roger Biosimilars: current status and future directions Expert Opin. Biol. Ther. 10 2010 1011 1018
21. L. Zuñiga, and B. Calvo Regulatory aspects of biosimilars in Europe Trends Biotechnol. 27 2009 385 387
22. P.J. Declerck Biosimilar monoclonal antibodies: a science-based regulatory challenge Expert Opin. Biol. Ther. 13 2013 153 156
23. K.H. Carver An unofficial legislative history of the Biologics Price Competition and Innovation Act 2009 Food Drug Law 65 2010 671 818
24. M.C. Nick The US Biosimilars Act Pharma. Med. 26 2012 145 152
25. S. Kozlowski Developing the nation's biosimilars program N. Engl. J. Med. 365 2011 385 388.