Samsung Bioepis Co., Ltd., Incheon, 21987, Republic of Korea.
BioDrugs. 2023 Mar;37(2):271-277. doi: 10.1007/s40259-023-00581-x. Epub 2023 Jan 31.
Biologics, regardless of whether they are biosimilars or reference products, are inherently variable due to their size, complexity, and the manufacturing process involved to produce them. Since a drift or evolution of quality attributes of a biologic may impact its clinical safety or efficacy, it is critical for the manufacturer to carefully control the manufacturing process and monitor the quality attributes of a biologic.
The aim of this study was to demonstrate that the quality profile of the SB5 drug product has been consistent over its production history from 2013 to 2022. SB5 is a biosimilar referencing adalimumab (Humira, trademark of AbbVie Biotechnology Ltd) and SB5 has been approved by 14 regulatory authorities including the European Commission in August 2017 (brand name Imraldi™) and the US Food and Drug Administration in July 2019 (brand name Hadlima™).
A total of 93 SB5 drug product batches manufactured between 2013 and 2022 were analyzed for a series of release parameters to evaluate the consistency in their critical quality attributes including purity, charge variants, and functional activities (TNF-α binding activity and TNF-α neutralizing potency).
The purity, charge variants, and functional activities of all batches were consistent over time and within the stringent acceptance criteria defined by regulatory agencies to ensure the safety and efficacy of SB5.
The data presented in this study provide evidence that the quality of SB5 has remained consistent and tightly controlled even through process changes such as manufacturing site transfers and change in formulation.
生物制剂无论是否为生物类似药或参比制剂，由于其大小、复杂性以及生产过程的原因，其质量属性固有地存在变异性。由于生物制剂质量属性的漂移或演变可能会影响其临床安全性或疗效，因此制造商必须仔细控制生产过程并监测生物制剂的质量属性。
本研究旨在证明 SB5 药物产品的质量概况在 2013 年至 2022 年的生产历史中一直保持一致。SB5 是一种参照阿达木单抗（Humira，艾伯维生物技术有限公司的商标）的生物类似药，并且已经获得包括欧盟委员会（2017 年 8 月，商品名 Imraldi™）和美国食品和药物管理局（2019 年 7 月，商品名 Hadlima™）在内的 14 个监管机构的批准。
分析了 2013 年至 2022 年间生产的 93 批 SB5 药物产品，以评估其关键质量属性的一致性，包括纯度、电荷变异体和功能活性（TNF-α 结合活性和 TNF-α 中和效力）。
所有批次的纯度、电荷变异体和功能活性均随时间保持一致，且符合监管机构定义的严格接受标准，以确保 SB5 的安全性和疗效。
本研究提供的数据表明，即使经历了生产场地转移和配方变更等工艺变更，SB5 的质量仍保持一致且受到严格控制。
