College of Pharmacy, University of Baghdad, Baghdad, Iraq.
College of Medicine, University of Baghdad, Baghdad, Iraq.
Regul Toxicol Pharmacol. 2020 Nov;117:104768. doi: 10.1016/j.yrtph.2020.104768. Epub 2020 Aug 27.
Biological medicines have significantly altered treatment for many patients with chronic diseases such as cancers, autoimmune diseases, and diabetes. However, the high cost of biological medicines has limited patients' access to them. Iraq is one of the countries that have decided to increase access to these medicines through biosimilars, which are copies of originator biological medicines. Prior to 2019, the Iraqi National Regulatory Authority (NRA) had no clear guidelines in place for biosimilars uptake. Therefore, approvals of many biosimilars were delayed. As a response to that, a new pivotal committee was found within this authority, and the first version of Iraqi basis and guidelines for the approval of biosimilars was enacted. With the implementation of the Iraqi biosimilars guidelines and escalating the cooperation within the Iraqi NRA, many benefits have been attained in a short time including the approval of many essential biosimilar products which has resulted in a total cost savings estimated to exceed 50 million USD in just the year 2020. However, there are still some barriers towards making the utmost benefit from biosimilars in Iraq, such as lack of familiarity of these products among the Iraqi health care providers which requires appropriate biosimilars-awareness enhancement strategies.
生物制药极大地改变了许多慢性病患者的治疗方法，如癌症、自身免疫性疾病和糖尿病。然而，生物制药的高成本限制了患者对这些药物的可及性。伊拉克是通过生物类似药（即原创生物制药的复制品）增加这些药物可及性的国家之一。在 2019 年之前，伊拉克国家监管机构 (NRA) 没有明确的生物类似药采用指南。因此，许多生物类似药的批准被推迟。作为对此的回应，在该机构内成立了一个新的核心委员会，并颁布了伊拉克生物类似药批准的基础和指导方针的第一版。随着伊拉克生物类似药指南的实施和伊拉克 NRA 内部合作的加强，在短时间内取得了许多成果，包括批准了许多基本的生物类似药产品，仅在 2020 年就节省了估计超过 5000 万美元的总成本。然而，在伊拉克要从生物类似药中获得最大效益仍存在一些障碍，例如伊拉克医疗保健提供者对这些产品不熟悉，这需要采取适当的生物类似药意识提升策略。
