References
- The Patient Protection and Affordable Care Act. Public Law 111–148; March 23, 2010. https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf
- Islam I. Rising cost of drugs: Where do we go from here? Health Affairs Blog; August 31, 2015. http://healthaffairs.org/blog/2015/08/31/risingcostofdrugswheredowegofromhere/
- US Food and Drug Administration. Information on biosimilars; May 10, 2016. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
- Generics and Biosimilars Initiative. Biosimilars approved in Europe; June 16, 2017. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
- Aitken M, editor. Medicines use and spending in the U.S. A review of 2016 and outlook to 2021. Report by the QuintilesIMS Institute; May 4, 2017. http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports
- Jha A, Upton A, Dunlop WC, et al. The budget impact of biosimilar infliximab (Remsima®) for the treatment of autoimmune diseases in five European countries. Adv Ther 2015;32:742-56
- Brodszky V, Baji P, Balogh O, et al. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ 2014;15(Suppl 1):S65-S71
- Aapro M, Cornes P, Sun D, et al. Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Ther Adv Med Oncol 2012;4:95-105
- Pfizer announces the US availability of biosimilar Inflectra® (infliximab-dyyb) (press release). Pfizer; October 17, 2016. http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_the_u_s_availability_of_biosimilar_inflectra_infliximab_dyyb
- Sagonowsky E. Targeting a $5 billion brand, Samsung and Merck launch Remicade biosim at 35% discount. FiercePharma; July 24, 2017. http://www.fiercepharma.com/pharma/samsung-merck-launch-remicade-biosim-at-35-discount
- FDA approves first biosimilar product Zarxio (press release). Food and Drug Administration; March 6, 2015. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
- US 351(k) biosimilar filings: biosimilar drug status in the US: FDA filing dates and actions. Biosimilars Review & Report; June 6, 2017. https://biosimilarsrr.com/us-biosimilar-filings/
- Scott Morton F, Dora Stern A, Stern S. The impact of the entry of biosimilars: evidence from Europe. Harvard Business School Working Paper, No. 16-141, June 2016 (Revised July 2017)
- Grabowski HG, Guha R, Salgado M. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. Health Aff 2014;33:1048-57
- Mulcahy AW, Predmore A, Mattke S. The cost savings potential of biosimilar drugs in the United States. RAND Corporation; 2014. https://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf
- Miller S. The $250 billion potential of biosimilars. Express Scripts; April 23, 2013. http://lab.express-scripts.com/lab/insights/industry-updates/the-$250-billion-potential-of-biosimilars
- Miller S. Two biosimilars to save $22.7 billion. Express Scripts; December 4, 2014. http://lab.express-scripts.com/lab/insights/drug-options/infographic-two-biosimilars-to-save-227-billion
- Aitken M. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. IMS Institute for Healthcare Informatics; March 2016. http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf
- Bechtel J. Sandoz launches Zarxio at 15% lower price than Neupogen. FDA News; September 11, 2015. http://www.fdanews.com/articles/173036-sandoz-launches-zarxio-at-15-percent-lower-price-than-neupogen
- Brook RA, Carlisle JA, Smeeding JE. The management of specialty drugs, specialty pharmacies and biosimilar drugs in the United States. Value Health 2017;20:A26
- Hakim A, Ross JS. Obstacles to the adoption of biosimilars for chronic diseases. JAMA 2017;317:2163-4
- Pearson C. Patient out-of-pocket costs for biosimilars in Medicare Part D. Avalere Health; April 2016. http://go.avalere.com/acton/attachment/12909/f-02c0/1/-/-/-/-/20160412_Patient%20OOP%20for%20Biosimilars%20in%20Part%20D.pdf
- Medicare Part B drug payment policy issues: Chapter 2. Medicare Advisory Commission; June 17, 2017. http://www.medpac.gov/docs/default-source/reports/jun17_ch2.pdf?sfvrsn=0
- Can biosimilar drugs lower Medicare Part B drug spending? Leveraging new drug alternatives could reduce costs. Pew Charitable Trusts; January 2017. http://www.pewtrusts.org/∼/media/assets/2017/01/leveraging-biosimilars-to-lower-medicare-part-b.pdf
- Manolis CH, Rajasenan K, Harwin W, et al. Biosimilars: opportunities to promote optimization through payer and provider collaboration. J Manag Care Pharm 2016;22(9 Suppl):S3-S9
- Danese S, Fiorino G, Michetti P. Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] members: an updated survey. J Crohns Colitis 2016;10:1362-5
- Considerations in demonstrating interchangeability with a reference product guidance for industry. Food and Drug Administration; January 2017. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf
- Moots R, Azevedo V, Coindreau JL, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology and dermatology inflammatory conditions: considers for the clinician. Curr Rheumatol Rep 2017;19:37
- Jørgenson KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet 2017;389:2304-16
- Pollack A. Makers of Humira and Enbrel using new drug patents to delay generic versions. New York Times; July 15, 2016. https://www.nytimes.com/2016/07/16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?_r=0)
- Sandoz v Amgen. No. 15-1039. 582 US ___ 2017. https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf
- Lilly and Sanofi reach settlement agreement in US insulin glargine litigation (press release). Lilly; September 28, 2015. https://investor.lilly.com/releasedetail.cfm?releaseid=933401
- Standard list of formulary removals and updates. CVS Health; 2016. http://investors.cvshealth.com/∼/media/Files/C/CVS-IR-v3/documents/02-aug-2016/2017-standard-formulary-list-of-removals-and-updates.pdf
- Dangi-Garmilla S. UnitedHealth’s 2017 formulary to support generic and biosimilar drugs. AJMC.com; September 23, 2016. http://www.ajmc.com/newsroom/unitedhealths-2017-formulary-to-support-generic-and-biosimilar-drugs
- VA National Formulary Changes; January 2017. https://www.pbm.va.gov/nationalformulary.asp