Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.
Prep Biochem Biotechnol. 2021;51(8):731-737. doi: 10.1080/10826068.2021.1959346. Epub 2021 Aug 8.
Biotherapeutic products whose patent protection has expired yield way to the development and approval of the more affordable "follow on medicines," known as biosimilars. These products need to have been shown as comparable in terms of quality, safety, and efficacy to the reference product (RP). In countries of the Middle East and Africa (MEA), there is a tremendous rise in deaths related to non-communicable diseases (NCDs). This class of diseases contributes to more than 38 million deaths worldwide annually, and they account for 74% of all deaths in MEA regions. The African continent consists of 54 countries, with each country having its own regulatory authority. To date, of the 54 African states, South Africa is the only country that has established a clear regulatory framework for biosimilar approval. This article highlights the prospects of biosimilars in the MEA market. The regulatory framework in the various MEA countries has also been discussed.
生物治疗产品的专利保护期届满后，为了开发和批准更实惠的“后续药物”（称为生物类似药）而让路。这些产品需要在质量、安全性和疗效方面与参比产品（RP）具有可比性。在中东和非洲（MEA）国家，与非传染性疾病（NCD）相关的死亡人数急剧上升。这类疾病导致全球每年有超过 3800 万人死亡，占 MEA 地区所有死亡人数的 74%。非洲大陆由 54 个国家组成，每个国家都有自己的监管机构。迄今为止，在 54 个非洲国家中，南非是唯一一个为生物类似药批准建立了明确监管框架的国家。本文重点介绍了生物类似药在 MEA 市场的前景。还讨论了MEA 各国的监管框架。
