Strategic Planning and Operations, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
Expert Rev Clin Pharmacol. 2014 Mar;7(2):151-9. doi: 10.1586/17512433.2014.874281. Epub 2014 Jan 6.
Shortages of small-molecule injectable drugs have captured the attention of patients, healthcare providers, regulators and policy makers in recent years. While these shortages have several causes, non-compliance with current good manufacturing practice and subsequent shutdowns of manufacturing facilities have played a central role. Sterile injectable drugs are particularly susceptible to manufacturing quality disruptions because of their sensitivity to contamination. Biologics are subject to the same fill-finish contamination risk as sterile injectables, but their active ingredients are also sensitive to subtle changes in the manufacturing process and to storage and handling of their final dosage forms. Originator biologics will lose market exclusivity in the years ahead as patents expire and as competitors develop biosimilar products. The availability of therapeutic alternatives may provide opportunities to reduce costs and increase patient access, but this should not come at the expense of critical investments in the manufacturing of these complex and sensitive products.
近年来，小分子注射剂短缺引起了患者、医疗保健提供者、监管机构和政策制定者的关注。虽然这些短缺有多种原因，但不符合现行良好生产规范和随后的生产设施关闭在其中起着核心作用。由于对污染敏感，无菌注射剂特别容易受到生产质量中断的影响。生物制品与无菌注射剂一样，面临着同样的灌装污染风险，但它们的活性成分也对生产过程中的细微变化以及最终剂型的储存和处理敏感。随着专利到期以及竞争对手开发生物类似药产品，原研生物制品将在未来几年失去市场独占权。治疗性替代品的可用性可能为降低成本和增加患者可及性提供机会，但这不应该以牺牲对这些复杂和敏感产品制造的关键投资为代价。
