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ReportsnReports - Biosimilars china update

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This report gives an overview of biologic regulations in China and Insight into the key drivers and resistors to biogeneric uptake in the China

This report gives an overview of biologic regulations in China and Insight into the key drivers and resistors to biogeneric uptake in the China


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  • 1. Biosimilars: China UpdatePublished:September 2011No.Of Pages:51Price:US $ 1900IntroductionCurrently, there is no definition, guidance or pathway for biosimilars in China, withdomestically manufactured versions of biologics, known as biogenerics. Due to limited R&Dcapabilities, most domestic companies manufacture simple biologics, although there is agrowing shift towards the development of both novel and biogeneric monoclonal antibodiesand second-generation biologics.Features and benefits* An overview of biologic regulations in China* Insight into the key drivers and resistors to biogeneric uptake in the China* Assessment of the key marketed and pipelines in the Chinese biogenerics market.* Provides a snapshot of key major biogeneric players and the strategies they haveimplemented.HighlightsPoor enforcement of patent protection provides significant opportunities for domesticcompanies. Manufacturers also benefit from low development costs as well as governmentsupport. As a result, biogenerics are priced much lower in China compared to originators.It is mandatory for biologics (and biogenerics) approved as “new drugs” (i.e. those thatreference a product not currently marketed in China), to undergo full Phase I–III clinicaltrials. However, only Phase III clinical trials are required for biogenerics which reference aproduct that is marketed domestically.A protracted and complicated drug registration process increases regulatory approvaltimelines, impacting market access, with further delays for drugs not manufactureddomestically. Also, despite many biogenerics being reimbursed, low purchasing power stilllimits uptake in China.Table Of ContentsEXECUTIVE SUMMARYIntroductionStrategic scoping and focusDatamonitor key findingsBiologic regulatory overview
  • 2. Drivers and resistors for biologics uptakeMarketed and pipeline biologicsKey biologic players in the Chinese marketRelated reportsCHINA – BIOLOGIC REGULATORY OVERVIEWNo biosimilars pathway yet exists in ChinaRegulatory approval criteria for biologics in ChinaCHINA – D RIVERS AND RESISTORS FACING BIOGENERICS IN CHINADrivers of biogeneric development in ChinaPatent protection is poorly enforced leading to opportunities for domestic biologicsmanufacturersLow development costs aid market entryGovernment support of the domestic biopharmaceutical industryDomestic companies enter partnerships to facilitate development of biologics for theChinese marketDrivers of biogenerics uptake in ChinaCost-containment will drive uptake of biogenericsBiogenerics are priced much lower in China compared to originatorsBiogenerics are reimbursed as List B drugs on the NRDLResistors impacting biogeneric uptake in ChinaProtracted and complicated drug registration increases regulatory approval timelines,impacting market accessLow purchasing power, a high proportion of out-of-pocket expenditure, and brand loyaltylimit access to biogenericsCHINA – MARKETED AND PIPELINE BIOLOGICSBiologics sales in ChinaMarketed biologics in ChinaMonoclonal antibodies are set to drive sales in the Chinese biologics marketSecond-generation biologicsCHINA – KEY BIOLOGICS PLAYERSCP Guojian Pharma3SBioGan Lee PharmaceuticalsJiuyuan GeneShuanglu PharmaceuticalBibliographyPublication and online articlesDatamonitor reportsAppendixExchange rates used in this report
  • 3. LIST OF TABLESTable: Pipeline and marketed biogeneric monoclonal antibodies in China, 2011Table: Snapshot of domestic biologic companies’ biologic and biogenerics portfolios, 2011Table: Minimum numbers of patients enrolled in clinical trials for biologics applications inChinaTable: Patent expiry date for top 10 selling biologics in ChinaTable: Pharmaceutical companies engaged in biologics-related deals in China, 2009–11Table: Examples of key biotech-university partnerships in ChinaTable: Biosimilar discount difference versus reference brand in key markets (%), 2010Table: Biologics included on the 2004 and 2009 NRDLs in ChinaTable: Monoclonal antibodies developed and marketed by domestic companies in China,2011Table: Monoclonal antibody development deals in China, 2009–11Table: Pipeline of domestically developed monoclonal antibodies in China, 2011Table: Snapshot of domestic biologic companies’ biologic and biogenerics portfolios, 2011Table: CPGJ – pipeline and marketed product portfolio, 2011Table: Comparison of Yi Sai Pu to Enbrel and Qiang Ke, 2011Table: 3SBio – pipeline and marketed product portfolio, 2011Table: Gan Lee Pharmaceuticals – pipeline and marketed product portfolio, 2011Table: Jiuyuan Gene – pipeline and marketed product portfolio, 2011Table: Shuanglu Pharmaceutical – pipeline and marketed product portfolio, 2011Table: Currency exchange rates, 2011LIST OF FIGURESFigure: Biosimilars approval pathwaysFigure: Comparison of biosimilars guidelines across major markets, 2011Figure: Key factors influencing biogeneric development and uptake in ChinaFigure: China’s central government policies in favor of biotech development, 2006–11Figure: National biotech industrial zones in ChinaFigure: Comparison of treatment costs for selective biogenerics versus originator products inChina, 2011Figure: Approval pathway for biologics and biogenerics in ChinaFigure: Number of approved drug registrations in China, 2006–09Figure: Proportion of government and private health expenditure vs. personal disposableincome, in China and other major markets, 2009Figure: Sales of erythropoietin and filgrastim in China and the total Asia Pacific region,2006–10Figure: Types of biologics in China, 2011Figure: Number of marketed biologic products in China, 2010
  • 4. About Us:ReportsnReports is an online library of over 100,000+ market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: http://twitter.com/marketsreportsOur Facebook Page: http://www.facebook.com/pages/ReportsnReports/191441427571689Contact:Mr.Priyank7557 Rambler road,Suite727,Dallas,TX75231Tel: + 1 888 391 5441E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comVisit our Market Research Blog