Barbier Liese, Mbuaki Allary, Simoens Steven, Declerck Paul, Vulto Arnold G, Huys Isabelle
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, Netherlands.
Front Med (Lausanne). 2022 Mar 9;9:820755. doi: 10.3389/fmed.2022.820755. eCollection 2022.
Beyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use.
This study aims to (i) review biosimilar information and guidance provided by EMA and national medicines agencies and (ii) explore stakeholder perspectives on the role of regulators in enabling acceptance and use of biosimilars.
This study consists of (i) a comparative review of regulatory information and position statements across medicine agencies ( = 32) and (ii) qualitative interviews with stakeholders in Europe ( = 14).
The comparative analysis showed that regulatory information and guidance about biosimilars offered by national medicines agencies in Europe varies, and is limited or absent in multiple instances. Approximately 40% (13/31) of the national medicines agencies' websites did not offer any information regarding biosimilars, and for about half (15/31) no educational materials were provided. Only less than half of national medicines agencies provided guidance on biosimilar interchangeability and switching (8/31 and 12/31, respectively). Among the national medicines agencies that did offer guidance, the extent (e.g., elaborate position vs. brief statement) and content (e.g., full endorsement vs. more cautious) of the guidance differed substantially. Countries that have a strong involvement in EU level biosimilar regulatory activities generally had more elaborate information nationally. Interviewees underwrote the need for (national) regulators to intensify biosimilar stakeholder guidance, especially in terms of providing clear positions regarding biosimilar interchangeability and switching, which in turn can be disseminated by the relevant professional societies more locally.
This study revealed that, despite strong EU-level regulatory biosimilar guidance, guidance about biosimilars, and their use differs considerably across Member States. This heterogeneity, together with the absence of a clear EU-wide position on interchangeability, may instill uncertainty among stakeholders about the appropriate use of biosimilars in practice. Regulators should strive for a clear and common EU scientific position on biosimilar interchangeability to bridge this gap and unambiguously inform policy makers, healthcare professionals, and patients. Furthermore, there is a clear opportunity to expand information at the national level, and leverage EU-developed information materials more actively in this regard.
除了评估和批准之外，欧洲及各国监管机构在提供关于生物类似药及其研发、批准和使用背后科学的可靠信息方面发挥着关键作用。
本研究旨在（i）回顾欧洲药品管理局（EMA）和各国药品机构提供的生物类似药信息及指南，以及（ii）探讨利益相关者对监管机构在促进生物类似药接受和使用方面作用的看法。
本研究包括（i）对各药品机构（n = 32）的监管信息和立场声明进行比较性回顾，以及（ii）对欧洲利益相关者（n = 14）进行定性访谈。
比较分析表明，欧洲各国药品机构提供的关于生物类似药的监管信息和指南各不相同，在多种情况下存在信息有限或缺失的情况。约40%（13/31）的国家药品机构网站未提供任何关于生物类似药的信息，约一半（15/31）未提供任何教育材料。只有不到一半的国家药品机构提供了关于生物类似药可互换性和换药的指南（分别为8/31和12/31）。在提供指南的国家药品机构中，指南的程度（如详细立场与简短声明）和内容（如完全认可与更为谨慎）差异很大。深度参与欧盟层面生物类似药监管活动的国家通常在国内有更详细的信息。受访者认可（国家）监管机构加强对生物类似药利益相关者的指导的必要性，特别是在提供关于生物类似药可互换性和换药的明确立场方面，进而可由相关专业协会在地方层面进行传播。
本研究表明，尽管欧盟层面有强有力的生物类似药监管指南，但各成员国关于生物类似药及其使用的指南差异很大。这种异质性，再加上在可互换性方面缺乏明确的全欧盟立场，可能会在利益相关者中造成关于生物类似药在实际应用中适当使用的不确定性。监管机构应努力就生物类似药的可互换性形成明确且统一的欧盟科学立场，以弥合这一差距，并明确地为政策制定者、医疗保健专业人员和患者提供信息。此外，在国家层面有明显的机会扩大信息，并在这方面更积极地利用欧盟制定的信息材料。
