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《在中东使用生物类似药:综述文章》。

The Use of Biosimilars in the Middle East: Review Article.

机构信息

Rheumatology Unit, Department of Medicine, College of Medicine, University of Baghdad, Baghdad, Iraq.

Al-Nahrain College of Medicine, Baghdad, Iraq.

出版信息

Curr Rheumatol Rep. 2018 Jun 13;20(7):45. doi: 10.1007/s11926-018-0740-6.

Abstract

PURPOSE OF REVIEW

Biosimilars are of growing importance worldwide, and many leading countries are introducing them in their health care systems and are using them in many fields of medicine owing to their low price tags in comparison with the brands and to their similarities in terms of function and side effects. So we cannot look past them and continue to rely on the innovator drugs since many had proven their efficacies in number of researches and Trials, not to mention the burden that many diseases pose on the budgets of the third world countries making using a lower priced alternatives a much appealing choice for the decision makers. Many fields of medicine in Iraq have experiences with the use of these agents over the past few years like the use of vaccines, insulin, and Growth factors, but their use in rheumatic disorders is still unfamiliar in our country. Our main aim doing this Review was to go through the written data on use of biosimilars in nearby countries and regions and draw some information regarding Types used, Terms of use and market release, different related legislations- if any-, patient's selection criteria for their use in case of the presence of Brands, and examine the systems of successful pharmacovigilance, to guide us in producing our own guidance for perfect utilization of the newly arriving drugs.

RESULTS

Overall, there were 21 separate articles in which the biosimilars were mentioned as integral parts of the reviews and main body of subject. Even these reports have deficiencies in descriptions of types of drugs, Prices, Patient selection strategies and Efficacy studies.

CONCLUSIONS

The biosimilar use is still considered a new encounter in the Middle Eastern areas, many countries have never had any experience with their use, With Very little published data in this regard.

RECOMMENDATION

We advise the researchers and workers in this Region to pay more attention to documentation and publication of their works and experiences.

摘要

综述目的

生物类似药在全球范围内的重要性日益增加,许多领先国家正在将其引入医疗体系,并在医学的许多领域中使用,因为它们的价格比品牌药物低,而且在功能和副作用方面也相似。因此,我们不能忽视它们,继续依赖创新药物,因为许多药物在许多研究和试验中已经证明了它们的疗效,更不用说许多疾病给第三世界国家的预算带来的负担,使得使用价格更低的替代品对决策者来说是一个更有吸引力的选择。伊拉克的许多医学领域在过去几年中都有使用这些药物的经验,如疫苗、胰岛素和生长因子的使用,但它们在风湿性疾病中的使用在我国仍不为人知。我们进行这项综述的主要目的是查阅附近国家和地区关于生物类似药使用的书面数据,并从中提取一些有关使用类型、使用条件和市场投放、任何相关法规、在有品牌药物存在的情况下患者选择使用的标准,以及检查成功的药物警戒系统的信息,以便为我们自己制定新药物的完美利用指南提供指导。

结果

总的来说,有 21 篇单独的文章提到了生物类似药,它们是综述和主题的重要组成部分。即使这些报告在药物类型、价格、患者选择策略和疗效研究的描述方面也存在缺陷。

结论

生物类似药的使用在中东地区仍被认为是一种新的尝试,许多国家从未有过使用它们的经验,这方面的发表数据也很少。

建议

我们建议该地区的研究人员和工作人员更加关注他们的工作和经验的记录和发表。

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