| 医药生物技术专栏 |
|
|
|
|
| 我国生物仿制药发展现状与策略研究 |
| 解小刚, 吴晶 |
| 天津大学药物与科学技术学院 天津 300072 |
|
| 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 |
|
[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.
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
| |
Shared |
|
|
|
|
| |
Discussed |
|
|
|
|
