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| Study on Status and Countermeasures about Biosimilars in China |
| XIE Xiao-gang, WU Jing |
| School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China |
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Abstract As the number of biological patents are about to expire, with the affection about drug cost reducing, availability increasing and a huge market space and so on, there showed great interest on developmenting biosimilars,major companies have set foot in this area,however because of specificity of biosimilars, success is not so easy. Based on the above background, the external environment, the macroeconomic environment, policy environment, legal and regulatory environment of the domestic and international bio-pharmaceutical industry are analyzed, then the current key technology problems of biosimilar developed are described.Based on this, the main ga Pabout biosimilar companies between demestic and abroad is proposed.Based on the above analysis,SWOT analyze the strategy and proposes that China should be carry out SO strategy mainly and supplements with SW strategy is used. Finally, some suggestions are for reference.
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Received: 02 December 2011
Published: 25 March 2012
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[1] Georg-Burkhard K. Biosimilars-Science, status, and strategic perspective. European Journal of Pharmaceutics and Biopharmaceutics, 2009,72:479-486.
[2] Schellekens H. Follow-on biologics: challenges of the "next generation". Nephrol Dial Transplant, 2005,20 (4):31-36.
[3] Evaluate Pharma-Biotech set to Dominate Drug Industry Growth EP Vantage,20 09,6..http://www.evaluatepharma.com/universal/view.aspx?type=story&id=1887007&isEPVantage=yes.
[4] Simoens S, Verbeken G, Huys I.Market access of biosimilars: not only a cost issue.Oncologie,2011,13:218-221.
[5] Crommelin D, Bermejo T,.Bissig M. Biosimilars.generic versions of the first gen- eration of therapeutic proteins: do they exist?. Contrib Nephrol,2005,149:287- 294.
[6] Mellstedt H,Niederwieser D, Ludwig H.The challenge of biosimilars.Annals of Oncology,2008,19:411-419.
[7] EMA.Annex guideline on Similar Biological Medicinal Products Containing Biotechnology Derived Proteins as Active Substance: Non-clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Somatropin. 2006.. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c&jsenabled=true.
[8] Simon D R. Biosimilars: current status and future directions.Expert Opin Biol Ther,2010,10(7):1-8.
[9] Dietger N, Stephan S. Biosimilar agents in oncology?haematology: from approval to practice.European Journal of Haematology,2010,86:277-288.
[10] McCamish M, Woollett G. Worldwide experience with biosimilar development.Landes Bioscience,2011,3(2):212-220.
[11] Bennett C L, Luminari S, Nissenson A R, et al. Pure red-cell aplasia and epoetin therapy. N Engl J Med, 2004, 351: 1403-1408.
[12] EMA. Pharmacovigilance-Medicinal Products for Human Use and Veterinary MedicinalProducts.2004..http://ec.europa.eu/health/documents/eudral-ex/vol-9/index_en.htm.
[13] FDA.Guidance for Industry-Good Pharmacovigilance Practices and Pharmaco-epidemiologicAssessment.2005..http://www.fda.gov/downloads/Regula tory Information/Guidances/UCM126834.pdf.
[14] Erwin A B, Joseph P F J. Biosimilars and innovation: an analysis of the poss- ibility of increased competition in biopharmaceuticals.Future Med Che- m,2010,2(11):1641-1649.
[15] 彭严燕.生物仿制药市场及发展概况.科技产业资讯室.2009,11..http://iknow.stpi.org.tw/Post/Read.aspx?PostID=3499. Peng Y Y. Market and status about biosimilars. S&T Industry Information Room. 2009,11..http://iknow.stpi.org.tw /Post/Read.aspx? Post ID=3499.
[16] Hiroshi H, Mina T, Koji K. Industry views of biosimilar development in Japan. Health Policy,2009,91: 189-194.
[17] Amit B. A study on the state of the biopharmaceutical sector in India with emphasis on its exports. AHCMJ, 2009,5(1): 31-51.
[18] Ron S K,Dan A K. Quality by design applications in biosimilar pharmaceutical products. Accred Qual Assur,2008, 13:681-690.
[19] Ellen R S, Joseph E B. A trade agreement’s impact on access to generic drugs. Health Affairs, 2009:957-968.
[20] Aaron S K, Michael A F, Jerry A. Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spending. Health Affairs, 2006,25(6):1637-1647.
[21] Arachu C, Michael W. Access to generic antiretrovirals: inequality,intellectual property law, and international trade agreements. Cad. Saúde Pública, Rio de Janeiro, 2007,23(1):S85-S96.
[22] Chee P C, Mohamed A H,Mohd B B. Exploring community pharmacists’ views on generic medicines:a nationwide study from Malaysia. Int J Clin Pharm,2011, 33:124-131.
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