Copenhagen Centre for Regulatory Science (CORS), Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
PLoS One. 2022 Jan 11;17(1):e0262537. doi: 10.1371/journal.pone.0262537. eCollection 2022.
Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
医疗体系在生物类似药替代是否应成为常规实践这一问题上已达到临界点。为了推动讨论，本研究旨在调查药品管理机构和制药行业专家对生物类似药可互换性所依据的科学的看法。我们采用实证定性研究方法，使用跨学科方法（包括监管科学、法律和制药政策）进行半结构化访谈。2018 年 9 月至 2019 年 8 月期间，共有 25 名具有生物制品经验的人员参与了研究。其中 8 名参与者为欧盟国家药品管理局监管人员，17 名参与者具有制药行业背景：其中 5 名来自两家仅生产原研药的公司，4 名来自同时拥有生物类似药和原研药产品的两家公司，8 名来自 7 家仅生产生物类似药的公司。两名分析师独立进行了归纳内容分析，得出以数据为驱动的主题，捕捉数据的含义。参与者报告称，可互换性不仅仅是生物类似药与参比产品之间相似性的科学问题：它还涉及监管实践和信任。参与者总体上对通过转换（即有医生参与）用生物类似药产品替代参比产品背后的科学充满信心。然而，他们对与医生不参与相关的生物类似药替代的科学风险的看法存在分歧。几乎所有参与者都认为不需要额外的科学数据来支持替代。此外，由于转换研究规模较小，参与者认为美国要求进行的转换研究不适合获得科学确定性。不清楚为什么生物类似药转换被视为比替代更安全；因此，我们预计在不久的将来，将有更多的政策辩论来讨论生物类似药替代。我们敦促欧洲和英国的政策制定者和监管机构阐明他们对生物类似药替代的愿景；这两个先行者的立场很可能会影响其他司法管辖区对生物类似药使用的未来。
