Barriers to market uptake of biosimilars in the US
Barriers to market uptake of biosimilars in the US
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DOI：
10.5639/gabij.2014.0303.028
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发表时间：
2014-01-01
影响因子：
--
通讯作者：
Riggs, Kim
中科院分区：
文献类型：
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作者：
Felix, Abigail E.;Gupta, Anumeha;Riggs, Kim
背景：在美国，作为平价医疗法案的一部分，建立了生物仿制药的新审批途径。生物仿制药预计将增加治疗选择并降低生物制品支出的增长。生物仿制药在美国的商业前景将如何发展尚不确定。从监管、审批和市场的角度来看，欧洲在生物仿制药方面领先于美国。可以从欧洲的经验中吸取教训。目的：研究美国生物仿制药市场采用方面的挑战和机遇。方法：我们回顾了过去五年发表的有关生物仿制药开发和市场采用主题的 Medline 索引手稿和灰色文献。本次审查中收集的数据为针对付款人和医生的两项利益相关者调查的开展提供了信息。 主要调查结果：几乎所有接受调查的医生都认为，如果生物仿制药获得美国食品和药物管理局 (FDA) 批准，该产品将在安全性和有效性方面与原研生物药表现相似。大多数医生表示，一旦获得 FDA 批准，他们可能会立即开出生物仿制药。此外，大多数医生愿意将现有患者从原研生物药转为生物仿制药。所有付款人受访者都打算通过使用处方分级引导患者和医生使用生物仿制药来区分原研生物药和生物仿制药，从而促进生物仿制药的采用。大多数付款人表示他们会建议生物仿制药的治疗转换。 75% 的付款人受访者期望生物仿制药有 15-35% 的价格折扣。讨论：医生在决定向现有患者开生物仿制药时会表现出谨慎态度。付款人将寻求监管机构的指导以获得进一步的支持。为了最大限度地节省成本，付款人可能会采用处方管理工具，例如原研药更高的成本分摊和生物仿制药更低的成本分摊。为了确保生物仿制药的上市后安全性和有效性的获取和监控，付款人可以通过证据开发安排的覆盖建立患者登记处。生物仿制药15-35%的预期价格折扣并不大。此外，制造商可能会利用原研生物制品的较高折扣作为采用生物仿制药的障碍。因此，生物仿制药制造商可能必须像对待任何其他品牌产品一样对待生物仿制药。最后，生物仿制药将受到同一治疗类别中新生物制剂的竞争，包括对现有原研药的逐步改进。
Background: In the US, a new approval pathway for biosimilars has been established as part of the Affordable Care Act. Biosimilars are anticipated to increase treatment options and lower the growth in spending on biologicals. How the commercial prospects for biosimilars will play out in the US is uncertain. From a regulatory, approvals, and market standpoint, Europe is ahead of the US with respect to biosimilars. Lessons may be drawn from European experience.Objective: To examine challenges and opportunities with respect to market uptake of biosimilars in the US.Methods: We reviewed Medline-indexed manuscripts and grey literature published in the past five years on the topics of biosimilar development and market uptake. The data collected in this review informed the development of two stakeholder surveys for payers and physicians.Main Survey Results: Almost all physicians surveyed believe that if a biosimilar is approved by the US Food and Drug Administration (FDA), the product will perform similarly to the originator biological with regard to safety and efficacy. Most physicians say they will likely prescribe biosimilars as soon as they are approved by FDA. Additionally, the majority of physicians feel comfortable switching an existing patient from the originator biological to a biosimilar. All payer respondents intend to promote biosimilar uptake by differentiating between the originator biological and biosimilar through the use of formulary tiering to steer patients and physicians towards biosimilars. Most payers said they would recommend therapeutic switching of biosimilars. Seventy-five per cent of payer respondents expect biosimilars to have a 15-35% price discount.Discussion: Physicians will display caution when deciding on prescribing biosimilars to existing patients. Payers will look to regulatory authority guidance for further support. To maximize cost savings, payers will likely employ formulary management tools, such as higher cost sharing for originators and lower cost sharing for biosimilars.To ensure access to and monitoring of post-marketing safety and effectiveness of biosimilars, payers may establish patient registries through coverage with evidence development arrangements.The expected price discount of 15-35% for biosimilars is not large. Furthermore, higher rebates on originator biologicals may be used by manufacturers as a barrier to adopting biosimilars. Therefore, biosimilar manufacturers will likely have to treat biosimilars as any other branded product. Finally, biosimilars will be subject to competition from new biologicals in the same therapeutic class, including incremental improvements to existing originators.