Biosimilarity in Latin America

被引：2

作者：

Chiann, Chang ^{[1
]}

Teixeira, Leonardo de Souza ^{[2
]}

de Santana E Silva Cardoso, Fabiana Fernandes ^{[2
]}

Cesar, Isabela da Costa ^{[2
,3
]}

Pianetti, Gerson Antonio ^{[3
]}

机构：

[1] Univ Sao Paulo, Inst Math & Stat, Dept Stat, Rua Matao, BR-05315970 Sao Paulo, SP, Brazil

[2] Inst Pharmaceut Sci, Goiania, Go, Brazil

[3] Univ Fed Minas Gerais, Dept Pharmaceut, Fac Pharm, Belo Horizonte, MG, Brazil

来源：

GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL | 2013年 / 2卷 / 02期

关键词：

Biosimilarity; complex drugs; Latin America;

D O I：

10.5639/gabij.2013.0202.021

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these complex drugs will ensure that evidence of safety and efficacy is obtained before approval. Biosimilars are high on the health-policy agenda because they are less costly and potentially more accessible, and also because of the imminent expiration of a number of patents on biological products. Within individual Latin American countries, the regulatory processes and stages of implementation vary.

引用

页码：94 / 96

页数：3

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