Abstract

Biosimilars are the biological drugs that are granted after the expiry of the patent of an affirmed innovator. Asia Pacific countries are characterized by significant demand as they account for majority of the world population and poor affordability due to low per capita income in most regions. Some of these countries offer potential to emerge as global suppliers of affordable, safe and efficacious biosimilars. This article highlights the prospects of biosimilars in the Asia Pacific market. Regulatory framework in the various countries is also discussed.

中文翻译：

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生物仿制药的监管注意事项：亚太地区。

摘要

生物仿制药是肯定的创新者的专利到期后授予的生物药品。亚太国家的特点是需求旺盛，因为它们占世界人口的大部分，并且由于大多数地区人均收入较低，因此承受能力较差。其中一些国家提供了成为负担得起的，安全的和有效的生物仿制药全球供应商的潜力。本文重点介绍了亚太地区生物仿制药的前景。还讨论了各国的监管框架。