Transitioning Long-Acting Products to a Generic Marketplace: What's Missing?
Transitioning Long-Acting Products to a Generic Marketplace: What's Missing?
复制标题
将长效产品过渡到通用市场：缺少什么？
DOI：
10.1093/cid/ciac753
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Flexner,Charles
中科院分区：
文献类型：
--
作者：
BrownRipin,DavidH;Catlin,Kelly;Lewis,Linda;Resar,Danielle;Amole,Carolyn;Bollinger,RobertC;Flexner,Charles
开发和增加获得治疗包括人类免疫缺陷病毒(HIV)、结核病、病毒性肝炎和疟疾在内的高负担疾病的非专利口服药物，对降低全球发病率和死亡率产生了重大影响。然而，对于一些最脆弱和服务不足的人群来说，获得和坚持这些挽救生命的治疗仍然有限，对他们来说，污名、控制和自由裁量权对有关护理的决定至关重要。目前开发长效配方来治疗和预防这些疾病的努力可以克服其中的许多障碍。然而，将需要对这些创新产品进行仿制制造，以确保能够负担得起最有需要的社区和患者的机会。甚至在市场和制造成本明确之前，就需要对新基础设施进行战略投资，以确保不会延误获得这些新产品的机会，特别是对低收入和中等收入国家的患者来说。与传统的口服药物不同，长效产品在配方、包装和交付方面需要更大的投资。对长期生物等效性研究的要求将导致监管部门对仿制长效产品的审批进一步拖延，必须制定快速审批途径。从开发长效荷尔蒙避孕药和长效抗逆转录病毒产品中吸取的经验教训可能会提供一条前进的道路。
Development of and increased access to generic oral medications to treat high-burden diseases including human immunodeficiency virus (HIV), tuberculosis, viral hepatitis, and malaria have had a major impact on reducing global morbidity and mortality. However, access and adherence to these life-saving treatments remains limited for some of the most vulnerable and underserved populations, for whom stigma, control, and discretion are critical to decisions around care. Current efforts to develop long-acting formulations to treat and prevent these conditions could overcome many of these barriers. However, generic manufacturing of these innovative products will be required to ensure affordable access to the communities and patients in greatest need. Strategic investments in new infrastructure will be required even before markets and manufacturing costs are clear, to ensure that access to these new products is not delayed, particularly for patients in low- and middle-income countries. Unlike conventional oral medications, long-acting products require greater investment for formulation, packaging, and delivery. The requirement for long-term bioequivalence studies will introduce additional delays in regulatory approval of generic long-acting products, and expedited approval pathways must be developed. Lessons learned from the development of long-acting hormonal contraceptives and long-acting antiretroviral products may provide a way forward.