在非洲生产生物类似药的机遇和挑战
Amany E Abdel-Maged1, Margrit F Mikhaeil2, Ahmed I Elkordy3
1Egyptian Drug Authority (EDA), Cairo, Egypt.
Regulatory toxicology and pharmacology : RTP
|April 18, 2024
概括
非洲国家进口大多数药品. 本地化生物类似产品可以改善获取并降低成本,但存在重大开发,制造和监管挑战.
科学领域:
- 生物制药生产 生物制药生产
- 医疗保健系统 医疗保健系统
- 非洲卫生经济学
背景情况:
- 非洲的医疗保健系统严重依赖进口的生物药物,超过70%的药品消费是进口的.
- 这种依赖使政府预算受到压力,并限制了人口获得必需药物的机会.
研究的目的:
- 审查非洲国家在本地化生物类似生产方面的挑战和成就.
- 确定非洲生物类似药的开发,制造,评估和注册的关键障碍.
主要方法:
- 这项研究是对现有文献和关于发展中国家生物类似药生产的报告的综述,重点是非洲.
- 分析生物仿真本地化过程中的挑战和成功.
主要成果:
- 在生物类似物本地化的所有阶段存在重大障碍,包括研究和开发,规模制造,质量评估和监管批准.
- 尽管面临挑战,但仍有新兴的成就和成功本地化的潜在途径.
结论:
- 在非洲本地化生物类似产品的生产提出了实质性的但可以克服的挑战.
- 解决这些障碍对于提高医疗保健准入,降低成本和改善整个非洲大陆的健康结果至关重要.
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