Transcription of 歐盟EMA於2012年7月提出「A型血友病患者產生抑 …
1 RegMed 2013 Vol. 31 1 1 2 (biological products) DNA (recombinant DNA technology) (cell line) 1921 DNA DNA 1973 Herbert Boyer Stanley Cohen (scalable) (venture capitalist) Robert Swanson Boyer Genentech ( Genentech )
2 1982 Genentech Eli Lilly Humulin 1 2 RegMed 2013 Vol. 31 2 1984 Georges K hler Nils Kai Jerne C sar Milstein (1975 ) B ( ) (myeloma cells) hybridoma 1994 1996 chimera rituximab (MabThera ) cetuximab (Eribitux ) humanized ( non-human ) trastuzumab (Herceptin ) bevacizumab (Avastin ) 2002 humanized adalimumab (Humira ) 155 100 AIDS/HIV (Aspirin)
3 180 Daltons 5,808 Daltons 30 (erythropoietin) 5 30,400 Daltons 150,000 Daltons ( CPJ/RPC May/June 2010 Vol. 143, No. 3) RegMed 2013 Vol. 31 3 (post-translational modifications) glycoproteins (host cell development) (Quality Attributes) (product quality tests) >2000 <100 (critical process steps) >5000 <100 (process data entries)
4 >60,000 <4000 2015 2011 20 RegMed 2013 Vol. 31 4 (the same) (similar) ( ) (European Medicines Agency, EMA) 2005 10 30 (Guideline on Similar Biological Products)
5 2006 6 1 G-CSF hGH insulin EPO 2009 interferon- low molecular weight heparin 2011 FSH interferon- 2012 EMA 2010 11 18 2011 5 31 6 2012 5 30 2012 12 1 ( Food and Drug Administration, US-FDA) 2006 Omnitrope US-FDA 2008 11 21 2010 12 22 2012 1 6 ( ) 2013 2 20 ( ) RegMed 2013 Vol. 31 5 (Antibody-Drug Conjugate, ADC) ADC ADC ADC (therapeutic window) ADC Mylotarg gemtuzumab calicheamicin ADC ADC 2000 2010 ADC Adcetris Seattle Genetics 2011 2013 2 22 Her2(+) ADC Kadcyla trastuzumab maytansinoid ADC ADC 1.
6 Leigh Revers and Eva Furczon, An introduction to biologics and biosimilars. Part I: Biologics:What are they and where do they come from? CPJ/RPC May/June 2010 Vol. 143, No. 3 2. Leigh Revers and Eva Furczon, An introduction to biologics and biosimilars. Part II: Biologics:What are they and where do they come from? CPJ/RPC July/August 2010 Vol. 143, No. 4 3. Plotkin SA. Vaccines: past, present and future. Nat Med2005;11 Supp 4:S5-11 4. Sneader W. History of insulin. Encyclopedia of life sciences 2001 April 25 RegMed 2013 Vol. 31 6 5. Rosenfeld L. Insulin: discovery and controversy. Clin Chem 2002;48(12):2270-88. 6. Strettona AO. The fi rst sequence: Fred Sanger and insulin. Genetics 2002;162(2):527-32. 7. Cohen SN, Chang AC, Boyer HW, Helling RB.
7 Construction of biologically functional bacterial plasmids in vitro. Proc NatlAcad Sci USA 1973;70(11):3240-4. 8. Goeddel DV, Levinson AD. Obituary: Robert A. Swanson (1947 99). Nature 2000;403(6767):264. 9. Abate T. The birth of biotech: how the germ of an idea became the genius of Genentech. San Francisco Chronicle. 2001 April 1 10. Sharma B. Immunogenicity of therapeutic proteins. Part 3: impact of manufacturing changes. Biotechnol Advances 2007;3(25):325-31. 11. Casadevall N, Eckardt K, Rossert J. Epoetin-induced autoimmune pure red cell aplasia. J Am Soc Nephrol 2005;16(1 Suppl):S67-9. 12. Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm Sci 2004;3:43-7. 13. Schellekens H. Manufacture and quality control of biopharmaceuticals.
8 14. Sadamoto R, Nishimura S. Glycosylation engineering of glycoproteins. Japan: Springer Berlin Heidelberg; 2008. 15. Emerging health care issues: follow-on biologics drug competition. Federal Trade Commission Report, 2009 16. Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies non-Clinical and Clinical Issues (EMA/CHMP/BMWP/403543/2010)
