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首页> 外文期刊>Biotechnology Advances: An International Review Journal >Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America
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Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America

机译：审查全球生物仿制药监管框架，重点关注墨西哥作为拉丁美洲新兴市场的案例

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摘要

The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries
机译：全球生物制药市场价值超过1000亿美元。这些产品中有将近90％将在未来十年内失去专利，从而导致其后续版本（称为“生物仿制药”）的商业化。在尺寸，结构，稳定性，微异质性，制造等方面，生物仿制药比化学合成的仿制药要复杂得多。因此，需要一个特定的监管框架来证明其与创新产品的可比性，质量，安全性。和功效。欧盟于2005年发布了第一个监管途径，并批准了14种生物仿制药。墨西哥最近为这些产品制定了明确的监管途径。它们的法律依据是2009年的《一般卫生法》第222条之二，2011年的《保健品条例》明确的规范以及墨西哥官方规范NOM-EM-001-SSA1-2012的进一步要求。这篇综述的目的是总结世界生物仿制药的监管途径，特别关注墨西哥的经验，从而为其他国家的法规制定做出贡献

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