In the past year, biologics sector sales grew by single digits, driven by monoclonal antibodies and insulin products. New product launches are showing mixed results and are facing rising challenges from changes to reimbursement policies.
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Anonymous. IMS Institute reports U.S. spending on medicines grew 2.3 percent in 2010, to $307.4 billion. (IMS Institute for Healthcare Informatics, 19 April 2011). http://www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=1648679328d6f210VgnVCM100000ed152ca2RCRD
Aggarwal, S. What's fueling the biotech engine? Nat. Biotechnol. 25, 1097–1104 (2007).
Aggarwal, S. What's fueling the biotech engine–2007. Nat. Biotechnol. 26, 1227–1233 (2008).
Aggarwal, S. What's fueling the biotech engine–2008. Nat. Biotechnol. 27, 987–993 (2009).
Aggarwal, S. What's fueling the biotech engine–2009–2010. Nat. Biotechnol. 28, 1165–1171 (2010).
Aggarwal, S. Targeted cancer therapies. Nat. Rev. Drug Discov. 9, 427–428 (2010).
Le, J. et al. Recombinant A2-specific TNFα-specific antibodies. US patent 7,070,775 (2006).
Harrison, C. Patent watch. Nat. Rev. Drug Discov. 10, 250–251 (2011).
Anonymous. Pfizer announces detailed pivotal data for investigational compound tofacitinib in rheumatoid arthritis to be presented at American College of Rheumatology 2011 Annual Scientific Meeting (Pfizer, 8 September 2011). http://www.marketwatch.com/story/pfizer-announces-detailed-pivotal-data-for-investigational-compound-tofacitinib-in-rheumatoid-arthritis-to-be-presented-at-american-college-of-rheumatology-2011-annual-scientific-meeting-2011-09-08
The CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 364, 1897–1908 (2011).
Gower, E.W. et al. Adverse event rates following intravitreal injection of Avastin or Lucentis for treating age-related macular degeneration. Association for Research in Vision and Ophthalmology (ARVO) 2011 Abstract no. 6644 Tuesday, May 3, 2011.
Daly, K.L. Improper payments: progress made but challenges remain in estimating and reducing improper payments. (US Government Accountability Office, 22 April 2009). http://www.gao.gov/new.items/d09628t.pdf
Anonymous. Regeneron announces EYLEA receives unanimous recommendation for approval for treatment of wet AMD from FDA advisory committee. (Regeneron, 17 June 2011). http://investor.regeneron.com/releasedetail.cfm?ReleaseID=585837
Krilov, L.R. et al. The 2009 COID recommendations for RSV prophylaxis: issues of efficacy, cost, and evidence-based medicine. Pediatrics 124, 1682–1684 (2009).
Xie, J. et al. Economic evaluation of denosumab compared with zoledronic acid in hormone-refractory prostate cancer patients with bone metastases. J. Manag. Care Pharm. 17, 621–643 (2011).
Laffler, M. Preparing for a pricing shift: Roche admits cost is an issue in oncology and beyond. Pink Sheet (June):28 (2011).
Rovenský, J. & Tuchynová, A. Systemic lupus erythematosus in the elderly. Autoimmun. Rev. 7, 235–239 (2008).
London, S. Lupus diagnosis can be an exercise in suspicion. Skin and Allergy News, 40, No. 8, August, 2009. http://skin.gcnpublishing.com/fileadmin/content_pdf/archive_pdf/vol40iss8/70392_main.pdf
Nault, K. The changing face of SLE therapy and why Benlysta isn't for everyone. The Lupus Magazine (2 April 2011).
Zinman, B. et al. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet 377, 924–931 (2011).
Cohen, J.A. et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N. Engl. J. Med. 362, 402–415 (2010).
Noyes, K. et al. Cost-effectiveness of disease-modifying therapy for multiple sclerosis: a population-based study. Neurology 77, 355–363 (2011).
Jacobson, I.M. et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N. Engl. J. Med. 364, 2405–2416 (2011).
Poordad, F. et al. Boceprevir for untreated chronic HCV genotype 1 infection. N. Engl. J. Med. 364, 1195–1206 (2011).
Sherman, K.E. et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N. Engl. J. Med. 365, 1014–1024 (2011).
Anonymous. When a drug costs $300,000. (NY Times, 23 March 2008). http://www.nytimes.com/2008/03/23/opinion/23sun3.html
Hayes, E. Dendreon readies for next Provenge hurdles: supply and reimbursement. Pink Sheet 71, No. 018, (May):3 (2010).
Anonymous. Dendreon Corp.'s CEO discusses Q2 2011 Results—Earnings Call Transcripts. Seeking Alpha (3 August 2011) http://seekingalpha.com/article/284445-dendreon-corp-s-ceo-discusses-q2–2011-results-earnings-call-transcript?part=qanda
Anonymous. 2011–2012 Prescription Drug Benefit Cost and Plan Design Report. (Pharmacy Benefit Management Institute, October, 2011).
Anonymous. The Use of Medicines in the United States: Review of 2010. (IMS Institute for Healthcare Informatics, April, 2011). http://www.imshealth.com/imshealth/Global/Content/IMS%20Institute/Documents/IHII_UseOfMed_report%20.pdf
Aggarwal, S. et al. Trends in comparative effectiveness of top 20 highest selling drugs. Abstract PHP59 presented at ISPOR 12th Annual European Congress October 24-27, 2009, Paris France.
Aggarwal, S. Biosimilars & biobetters: market access opportunities and regulatory challenges (Elsevier Business Intelligence Webinars, 17 August 2011). http://virtual.elsevierbi.com/AC081711LP.html
Kozlowski, S., Woodcock, J., Midthun, K. & Sherman, R.B. Developing the nation's biosimilars program. N. Engl. J. Med. 365, 385–388 (2011).
Anonymous. Biosimilar erosion of branded ESA market share will be more rapid in the US than in Europe. PR Newswire, November 4 (2010). http://www.prnewswire.com/news-releases/biosimilar-erosion-of-branded-esa-market-share-will-be-more-rapid-in-the-us-than-in-europe-106701783.html
SA thanks American Society of Clinical Oncology (ASCO), American College of Rheumatology (ACR), American Association of Liver Diseases (AASLD), American Heart Association (AHA), American Society of Hematology (ASH) and Biotechnology Industry Association (BIO) for providing support for this article.
The author declares no competing financial interests.
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Aggarwal, S. What's fueling the biotech engine—2010 to 2011. Nat Biotechnol 29, 1083–1089 (2011). https://doi.org/10.1038/nbt.2060
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