Dylst Pieter, Vulto Arnold, Godman Brian, Simoens Steven
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium Herestraat 49, O&N 2, P.O. Box 521, 3000, Leuven, Belgium,
Appl Health Econ Health Policy. 2013 Oct;11(5):437-43. doi: 10.1007/s40258-013-0043-z.
Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.
仿制药能提供与原研药同等高质量的治疗，但其价格要低得多。因此，仿制药为当局实现大幅节省开支提供了相当大的机会。目前，制药行业正在发生变化，许多制药公司已经改变了其研发和商业策略，将原研药部门和仿制药部门合并在一起。尽管如此，仿制药行业目前仍面临一些挑战：市场准入延迟；与原研药的价格差异有限；价格持续下行压力；以及一些关键利益相关者群体对仿制药的负面看法。这可能会危及仿制药制造业的长期可持续性。因此，政府必须在加速市场准入政策的同时，关注需求侧政策，因为只有确保高销量，仿制药行业才能提供具有竞争力和可持续性的价格。未来，仿制药行业将越来越多地寻求生物类似药和孤儿药的仿制药版本来拓展业务。
