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在低收入国家,仿制药和生物类似药在肿瘤学中的作用。

The role of generic medicines and biosimilars in oncology in low-income countries.

机构信息

Department of Child Health, University of Ghana Medical School, Accra, Ghana.

出版信息

Ann Oncol. 2013 Sep;24 Suppl 5:v29-32. doi: 10.1093/annonc/mdt326.

DOI:10.1093/annonc/mdt326
PMID:23975702
Abstract

Cancer cases are rising in developing countries which are already grappling with high levels of infectious diseases including human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (TB) and malaria. The United Nations (UN) including the World Health Organisation (WHO) have called on member states to establish strategies to deal with the increasing burden of non-communicable diseases, including cancer, in developing countries. The complexity of cancer care and management calls for innovative approaches in low resource settings especially since these settings are already grappling with huge challenges in healthcare including lack of funds, weak human resource base and lack of treatment guidelines. Whilst the cost of medications is by no means the only high cost in cancer care, the availability of affordable anti-cancer generic drugs and biologically similar therapeutic agents (biosimilars) will go a long way to reduce overall cost of cancer care. The high cost of anticancer medicines has been cited among the reasons whilst patients default in treatment. Non-proprietary anti-cancer agents--generics and biosimilars--often cost several times lower than their innovator branded counterparts. They can reduce the cost of care significantly and their multi-source origin often provide guarantee in supply. The use of generic and biosimilar products is hinged on the assumption that they are of assured quality and of the same pharmaceutical integrity as their innovator counterparts. The use of these products however is associated with challenges that must be understood and addressed. The quality of all generics and biosimilars should be rigorously controlled and assured. Measures to prevent counterfeit and sub-standard generics and biosimilars should be developed and the cold-chain must be maintained for all biosimilars. In addition to these, the WHO is encouraged to develop a prequalification scheme to assist countries without strong regulatory systems to procure anticancer generics and biosimilars of assured quality.

摘要

发展中国家的癌症病例正在上升,这些国家已经在努力应对包括人类免疫缺陷病毒/获得性免疫缺陷综合征(HIV/AIDS)、结核病(TB)和疟疾在内的高水平传染病。联合国(UN)包括世界卫生组织(WHO)已呼吁成员国制定战略,以应对发展中国家日益增加的非传染性疾病负担,包括癌症。癌症护理和管理的复杂性需要在资源有限的环境中采用创新方法,特别是因为这些环境已经在医疗保健方面面临巨大挑战,包括缺乏资金、人力资源基础薄弱以及缺乏治疗指南。虽然药物成本绝不是癌症护理的唯一高成本,但在负担得起的抗癌仿制药和生物类似治疗药物(生物类似药)的可用性将大大降低癌症护理的总成本。抗癌药物的高成本已被列为患者中断治疗的原因之一。非专利抗癌药物——仿制药和生物类似药——的成本通常比其创新品牌药物低几倍。它们可以显著降低护理成本,而且它们的多源来源通常可以保证供应。仿制药和生物类似药的使用取决于这样一个假设,即它们的质量有保证,与创新药物具有相同的药物完整性。然而,这些产品的使用与必须理解和解决的挑战有关。所有仿制药和生物类似药的质量都应严格控制和保证。应制定防止假冒和劣质仿制药和生物类似药的措施,并必须为所有生物类似药保持冷链。除此之外,鼓励世卫组织制定资格预审计划,以帮助没有强大监管系统的国家采购质量有保证的抗癌仿制药和生物类似药。

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