Last year, the biologics sector managed single-digit growth in the United States, driven mainly by products indicated for oncology, diabetes and autoimmune disorders. Lurking on the horizon, though, are challenges, such as pricing, competition and follow-on molecules.
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References
Aggarwal, S. Nat. Biotechnol. 27, 987–993 (2009).
Aggarwal, S. Nat. Biotechnol. 26, 1227–1233 (2008).
Aggarwal, S. Nat. Biotechnol. 25, 1097–1104 (2007).
Aggarwal, S. Nat. Rev. Drug Discov. 9, 427–428 (2010).
Pollack, A. FDA extends Avastin's use to breast cancer. New York Times 23 February 2008 <http://www.nytimes.com/2008/02/23/business/23drug.html>
Peterson, M. & Doherty, D. Roche may lose $1 billion a year on Avastin change. Bloomberg Businessweek 21 July 2010 <http://www.businessweek.com/news/2010–07–21/roche-may-lose-1-billion-a-year-on-avastinchange.html>
Anonymous. Pink sheet–FDA will revisit appropriate use of PFS endpoints at advisory committee. Friends of Cancer Research Newsletter, 2008 <http://www.focr.org/pink-sheet-fda-will-revisit-appropriate-use-of-pfs-endpoints-at-advisory-committee.html>
Krilov, L.R. et al. Pediatrics 124, 1682–1684 (2009).
Lowry, F. FDA panel nixes licensing request for motavizumab. Medscape Medical News (2010). <http://www.medscape.com/viewarticle/722903>; June 3, 2010.
Lowy, I. et al. N. Engl. J. Med. 362, 197–205 (2010).
FDA approves a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs). US Department of Health & Human Services, US Food and Drug Administration 16 February 2010 <http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm200847.htm>
Unger, E.F., Thompson, A.M., Blank, M.J. & Temple, R. N. Engl. J. Med. 362, 189–192 (2010).
<http://www.cms.gov/ESRDPayment/>
Information for Health care Professionals: Exantide (marketed as Byetta) 8.2008 update <http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm>.
Parks, M. & Rosebraugh, C. N. Engl. J. Med. 362, 774–777 (2010).
Genovese, M.C. et al. N. Engl. J. Med. 353, 1114–1123 (2005).
Vincenti, F. et al. N. Engl. J. Med. 353, 770–781 (2005).
Cohen, J.A. et al. N. Engl. J. Med. 362, 402–415 (2010).
McHutchison, J.G. et al. N. Engl. J. Med. 360, 1827–1838 (2009).
Anonymous. In pivotal phase 3 studies, Merck's investigational medicine boceprevir helped majority of patients with chronic Hepatitis C genotype 1 infection achieve sustained virologic response, the primary endpoint of the studies. Merck Newsroom 4 August 2010 <http://www.merck.com/newsroom/news-release-archive/research-and-development/2010_0804.html>
Colvin, H.C. & Mitchell, A.E. (eds.) Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C (The National Academies Press, 2010).
Kim, J.J. & Goldie, S.J. BMJ 339, b3884 (2009).
Peres, J. J. Natl. Cancer Inst. 102, 838–840 (2010).
Kelley, R.K. & Venook, A.P. N. Engl. J. Med. 363, 596–598 (2010).
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Aggarwal, S. What's fueling the biotech engine—2009–2010. Nat Biotechnol 28, 1165–1171 (2010). https://doi.org/10.1038/nbt1110-1165
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DOI: https://doi.org/10.1038/nbt1110-1165
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