非洲生物仿制药生产的机遇与挑战

IF 3 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology Pub Date : 2024-04-16 DOI:10.1016/j.yrtph.2024.105626

Amany E. Abdel-Maged , Margrit F. Mikhaeil , Ahmed I. Elkordy , Amany M. Gad , Mohamed M. Elshazly

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引用次数: 0

摘要

非洲国家的医疗系统严重依赖生物药品的进口和重新包装。非洲 70% 以上的医药产品依赖进口。生物仿制药的本地化生产可以减少非洲政府的开支，使民众更容易获得基本的医疗保健产品，从而对这些产品的供应和成本产生积极影响。然而，发展中国家，尤其是非洲国家，在生物仿制药本地化生产方面显然面临着各种障碍和困难。这些挑战包括开发、生产、评估和注册过程。在本综述中，我们将重点介绍生物仿制药本地化过程中遇到的重大障碍和取得的成就。

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Biosimilars production in Africa opportunities & challenges

The healthcare systems of African nations heavily rely on importing and repackaging biological medicine. More than 70% of the pharmaceutical products consumed in Africa are imported. The localization of biosimilar production can have a positive impact on the availability and cost of these products by reducing the expenses for African governments and making essential healthcare products more accessible to the population. However, it is evident that the developing countries, particularly African nations, face various obstacles and difficulties in localizing biosimilar production. These challenges encompass development, manufacturing, evaluation, and registration processes. In this review, we will highlight the significant hurdles and achievements encountered during the localization process of biosimilars.

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来源期刊

Regulatory Toxicology and Pharmacology 医学-毒理学

CiteScore

6.70

自引率

8.80%

发文量

147

审稿时长

58 days

期刊介绍： Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)