Swaying biosimilars market
Corresponding Author(s) : R.Kumanan
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 2 No. 4 (2014): 2014 Volume 2- Issue -4
Abstract
Biosimilars are having massive demand in future in order to provide good quality therapy for human well-being. Biosimilars also pronounced as biologics / biopharmaceuticals / follow-on biologics / subsequent entry biologics (SEB’s) with the statement of a biopharmaceutical drug deigned to have active properties similar to one that has previously been licensed. As per WHO biosimilars are defined as “a bio therapeutic product which is similar in terms of quality, safety and efficacy to an already licensed referenced bio therapeutic product”. Biosimilars can relieve the financial burden on healthcare systems and expand patient accessibility. This review embraces the significance, regulatory consideration, available regulatory guidelines and current market scenario on biosimilars.
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[1] Roger SD, Goldsmith D. Biosimilars: it’s not as simple as cost alone. J Clin Pharm Ther. 2008; 33: 459-64.
[2] Kanas SJ, Gayhane YN, Khandekar A, Gurav AS and Yadav AV; Biosimilars: an overview. Int J Pharm Sci res 2013; 4(6); 2132-2144.
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[5] Biologics Price Competition and Innovation Act of 2009, Pub.L.111-148, Sect. 7001-7003, 124 Stat.119. Mar.23, 2010.
[6] Huzair, Farah and Kale, Dinar (2011). Emergence of the Biosimilar Sector and Opportunitie of Developing Country Suppliers. Innogen.
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[8] BCC Research LLC, Global Demand For Biosimilars To Reach $3.6 Billion In 2016: May 25, 2012.
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[10] http://www.bccresearch.com/pressroom/bio/global-demand-biosimilars-reach-$3.6-billion-2016.
[11] http://imshealth.com/Core therapy areas for Biosimilars.
[12] http://www.marketsandmarkets.com/Market-Reports/biosimilars-40.html.
[13] https://www.frost.com/sublib/display-market-insight.do?id=241715269.
[14] http://www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-follitropin-alfa-and-somatropin.
[15] Killugudi Jayaraman: Indian companies marketing biosimilars in India. Nature Biotechnology 28, 883–884 (2010).
References
[2] Kanas SJ, Gayhane YN, Khandekar A, Gurav AS and Yadav AV; Biosimilars: an overview. Int J Pharm Sci res 2013; 4(6); 2132-2144.
[3] Rachel E Sherman; Center for Drug Evaluation and research: biosimilars guidance webinar. Feb 15, 2012.
[4] Shein-chung chow, assessing biosimilarities and interchangeability of biosimilars products under the biologics price competition and innovation act: Generics and Biosimilars Initiative Journal. 2013; 2(1): 20-5.
[5] Biologics Price Competition and Innovation Act of 2009, Pub.L.111-148, Sect. 7001-7003, 124 Stat.119. Mar.23, 2010.
[6] Huzair, Farah and Kale, Dinar (2011). Emergence of the Biosimilar Sector and Opportunitie of Developing Country Suppliers. Innogen.
[7] Roger SD; Biosimilars: Current status and future directions. Expert opin Biol Ther 2010; 10: 1011-1018.
[8] BCC Research LLC, Global Demand For Biosimilars To Reach $3.6 Billion In 2016: May 25, 2012.
[9] Rohan; Biosimilars markets worth $1,954 million by 2018: Press releases, Markets and Markets.
[10] http://www.bccresearch.com/pressroom/bio/global-demand-biosimilars-reach-$3.6-billion-2016.
[11] http://imshealth.com/Core therapy areas for Biosimilars.
[12] http://www.marketsandmarkets.com/Market-Reports/biosimilars-40.html.
[13] https://www.frost.com/sublib/display-market-insight.do?id=241715269.
[14] http://www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-follitropin-alfa-and-somatropin.
[15] Killugudi Jayaraman: Indian companies marketing biosimilars in India. Nature Biotechnology 28, 883–884 (2010).