title: Interferon-free therapy for hepatitis C, how prepared is Australia for biosimilars? creator: Lim, David creator: Hepworth, Julie creator: Siegel, Evan creator: van Driel, Mieke creator: Nissen, Lisa subject: 160508 Health Policy subject: 180115 Intellectual Property Law subject: Health policy subject: Pharmaceutical policy subject: Pharmaceuticals subject: Intellectual property subject: Patent description: The Hepatitis C virus (HCV) affects some 150 million people worldwide. However, unlike hepatitis A and B there is no vaccination for HCV and approximately 75% of people exposed to HCV develop chronic hepatitis. In Australia, around 226,700 people live with chronic HCV infection costing the government approximately $252 million per year. Historically, the standard approved/licenced treatment for HCV is pegylated interferon with ribavirin. There are major drawbacks with interferon-based therapy including side effects, long duration of therapy, limited access and affordability. Our previous survey of an at-risk population reported HCV treatment coverage of only 5%. Since April 2013, a new class of interferon-free treatments for chronic HCV is subsidised under the Pharmaceutical Benefits Scheme: boceprevir and telaprevir - estimated to cost the Australian Government in excess of $220 million over five years. Other biologic interferon-free therapeutic agents are scheduled to enter the Australian market. Use of small molecule generic pharmaceuticals has been advocated as a means of public cost savings. However, with the new biologic agents, generics (biosimilars) may not be feasible or straightforward, due to long patent life; marketing exclusivity; and regulatory complexity for these newer products. publisher: Menzies Centre for Health Policy date: 2013-10 type: Conference Paper format: application/pdf relation: https://eprints.qut.edu.au/62608/2/Pharm_IP_v7.pdf relation: Lim, David, Hepworth, Julie, Siegel, Evan, van Driel, Mieke, & Nissen, Lisa (2013) Interferon-free therapy for hepatitis C, how prepared is Australia for biosimilars? In Emerging Health Policy Research Conference, 14 October 2013, Darlington Centre, University of Sydney, Australia. (In Press) identifier: https://eprints.qut.edu.au/62608/ rights: Copyright 2013 The authors source: Faculty of Health