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期刊名称：药物分析杂志
主管单位：中国科学技术协会
主办单位：中国药学会承办：中国食品药品检定研究院
主编：金少鸿
地址：北京天坛西里2号
邮政编码：100050
电话：010-67012819,67058427 电子邮箱：ywfx@nifdc.org.cn
国际标准刊号：ISSN 0254-1793
国内统一刊号：CN 11-2224/R
邮发代号：2-237
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巴西生物制品的监管
Regulatory aspects of biological products in Brazil
单位：1. Brazilian Health Surveillance Agency(ANVISA), Brasília, Brazil;
2. Department of Statistics, Institute of Mathematics and Statistics, University of Sao Paulo, Sao Paulo, SP, Brazil;
3. Institute of Pharmaceutical Sciences, Goiania, GO, Brazil;
4. Department of Pharmacy, Pharmaceutical Sciences Faculty, University of Sao Paulo, Sao Paulo, SP, Brazil
单位(英文)：1. Brazilian Health Surveillance Agency(ANVISA), Brasília, Brazil;
2. Department of Statistics, Institute of Mathematics and Statistics, University of Sao Paulo, Sao Paulo, SP, Brazil;
3. Institute of Pharmaceutical Sciences, Goiania, GO, Brazil;
4. Department of Pharmacy, Pharmaceutical Sciences Faculty, University of Sao Paulo, Sao Paulo, SP, Brazil
分类号：
出版年·卷·期（页码）：2015,35 (5):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
创新和原研的生物治疗药品价格昂贵,限制了这些药品在病人中的广泛使用。由于一些生物治疗药品的专利已经或即将到期,巴西制药行业对于生产生物治疗类似药物的兴趣也在不断增长。生物治疗类似药物(SBP)开发的主要目的是确保患者以更实惠的价格获得治疗作用等效的生物治疗药品。生物制品和生物技术产品在巴西占用政府卫生预算的比例较大,所以巴西政府一直致力于在生物治疗药物的质量、安全和有效性得以保障的前提下,向市场中投入更多价格实惠的生物治疗类似药物,并加强其生产与供应,降低政府支出,从而惠及更多患者。本文介绍巴西SBP监管的现况。
-----英文摘要：---------------------------------------------------------------------------------------
The innovator and original biotherapeutic products are very costly thereby limiting their access to patients.As a number of biological products have been or are due to expire in the next few years, the interest in production of similar biotherapeutic products has been increasing within the Brazilian pharmaceutical industry.The development of similar biotherapeutic products(SBP)should be considered to ensure therapeutic equivalence of biotherapeutics products at more affordable prices.In Brazil, biological and biotechnological products account for a large percentage of the government health budget, the Brazilian government has a big interest in the possibility that more affordable products could be introduced into the market to increase their availability, reduce costs and improve access, but always is concerned with the quality, safety and efficacy of these products.Therefore, we report herein the SBP situation in Brazil.
-----参考文献：---------------------------------------------------------------------------------------
[1] RESOLUTION RDC N.315, FROM OCTOBER 26th 2005.Establishes the Technical Regulation of Registry, Post-Registry Alterations and Registry Revalidation of the Finished Biological Products[R/OL].[2014-10-14].http://s.anvisa.gov.br/wps/s/r/lg.
[2] Public Consultation CP n° 49/2010.Provides on the registration of new biological products and biological products, giving other provisions[R/OL].[2014-10-14].http://s.anvisa.gov.br/wps/s/r/lg.
[3] RESOLUTION-RDC No.55, DECEMBER 16, 2010.Provides on the registration of new biological products and biological products, giving other provisions[R/OL].[2014-10-14].http://s.anvisa.gov.br/wps/s/r/lg.
[4] RESOLUTION RDC No.49, DATED SEPTEMBER 2011.Provides on post-registration changes and inclusions, suspension and reactivation of manufacturing and cancellations of biological product registration, giving other provisions[R/OL].[2014-10-14].http://s.anvisa.gov.br/wps/s/r/lg.
[5] CASTANHEIRA LG, BARBANO DBA, RECH N.Current development in regulation of similar biotherapeutic products in Brazil[J].Biologicals, 2011, 39(5):308
[6] CHIANNC, TEIXEIRA LS, SANTANA FF, et al.Biosimilarity in Latin America[J].GaBI J, 2013, 2(2):94
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