Copenhagen Centre for Regulatory Science (CORS), Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, Copenhagen, 2100, Denmark.
Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
BioDrugs. 2021 May;35(3):351-361. doi: 10.1007/s40259-021-00478-7. Epub 2021 Apr 8.
A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics.
The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity.
Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis.
In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs.
The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
生物类似药是与已批准的生物药（参照药）高度相似的生物药。生物类似药的出现促进了竞争，进而降低了价格。改变当前生物类似药临床可比性试验的要求可能会降低生物类似药的开发成本，从而增加患者获得生物药的机会。
旨在确定业界和药品管理局监管机构对建立生物类似药相似性的欧洲生物类似药临床可比性试验要求的价值、必要性和未来发展的看法。
2018 年 9 月至 2019 年 8 月，对 8 名欧洲国家药品管理局监管机构和 17 名具有生物制品经验的制药公司员工或顾问进行了半结构化访谈。对数据进行了内容分析。
总体而言，参与者预计临床可比性试验要求将继续降低，特别是基于分析测试的进步和从先前生物类似药批准中获得的知识。然而，也存在竞争问题，如竞争、医生的信任和伦理考虑。参与者还报告说，任何降低或豁免生物类似药临床要求的新举措都需要有科学依据，并可能降低生物类似药的开发成本。
主要发现是生物类似药临床可比性试验要求在不久的将来可能会发生变化。需要明确如何确保理化数据、药代动力学/药效学研究以及药物在临床中的表现之间有足够的相关性，以及如何继续进行充分的免疫原性评估。明确这一点可以促进对下一批生物类似药的监管评估。
