Current trends for biosimilars in the Latin American market

Pub Date : 2020-06-15 DOI:10.5639/gabij.2020.0902.011
E. Ortiz-Prado, Jorge Ponce-Zea, J. Vásconez, Diana Castillo, Diana C Checa-Jaramilloz, Nathalia Rodríguez-Burneo, Felipe Andrade, Damaris P Intriago Baldeón, C. Galarza-Maldonado
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引用次数: 6

Abstract

The number of approved biological medicines in the global pharmaceutical market has increased in recent decades. However, their high costs have also promoted the development of biosimilar medicines, following the expiry of the patent of the reference drug. Biosimilars are approved medicines of biological origin which have no statistically significant differences in terms of quality, safety and therapeutic efficacy in comparison with the reference biological. Drugs marketed as biomimics meanwhile are copies of monoclonal antibodies and fusion proteins that have not demonstrated bioequivalence to their reference biologicals. Across the world, regulations have been developed to ensure the safety and efficacy of biosimilar products, which can reduce public health expenditure and improve patient access to biological medicines. As a result, Latin America has begun to invest in the development of these drugs. The objective of this literature review is to describe the development of the biosimilar and biomimic market in Latin America.
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拉丁美洲市场生物仿制药的当前趋势
近几十年来,全球制药市场上批准的生物药物数量有所增加。然而,随着参比药的专利到期,它们的高成本也促进了生物类似药的发展。生物仿制药是经批准的生物来源药物,与参比生物相比,在质量、安全性和疗效方面没有统计学上的显著差异。与此同时,作为仿生学上市的药物是单克隆抗体和融合蛋白的复制品,它们没有证明与其参考生物制剂具有生物等效性。在世界各地,已经制定了法规,以确保生物类似药产品的安全性和有效性,这可以减少公共卫生支出并改善患者获得生物药物的机会。因此,拉丁美洲已开始投资于这些药物的开发。这篇文献综述的目的是描述生物仿制药和仿生学市场在拉丁美洲的发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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