Gao Dong, Nie Lei, Yuan Junjie, Hu Feng, Wu Zhenhua, Lin Qunhai, Wang Haibin
BioRay Pharmaceutical Co., Ltd., Taizhou, China.
Hisun BioPharmaceutical Co., Ltd., Hangzhou, China.
J Pharm Sci. 2022 Apr;111(4):1142-1151. doi: 10.1016/j.xphs.2021.12.001. Epub 2021 Dec 3.
The characterization of a biosimilar drug HS016, the reference product adalimumab (Humira), and their biosimilarities were determined using physical chemistry and functional similarity tests. The primary and higher order structures, size and charge variants, glycosylation profiles, and in vitro potency of both antibodies were characterized both for unstressed and stability samples. Slight differences were observed in the relative levels of methionine oxidation, low molecular weight components, terminal lysine variant, high mannoses and galactosylated glycans between HS016 and Humira. However, no differences in antigen binding activity, Fc receptor affinity, antibody-dependent cell-mediated cytotoxicity or complemented-dependent cytotoxicity were found. The primary and higher order structures, physicochemical properties, and biological activity of HS016 and adalimumab were similar.
使用物理化学和功能相似性测试确定了生物类似药HS016、参比产品阿达木单抗（修美乐）的特性及其生物相似性。对未处理和稳定性样品的两种抗体的一级和高级结构、大小和电荷变体、糖基化谱以及体外效力进行了表征。在HS016和修美乐之间，甲硫氨酸氧化、低分子量成分、末端赖氨酸变体、高甘露糖和半乳糖基化聚糖的相对水平存在细微差异。然而，未发现抗原结合活性、Fc受体亲和力、抗体依赖性细胞介导的细胞毒性或补体依赖性细胞毒性存在差异。HS016和阿达木单抗的一级和高级结构、物理化学性质及生物学活性相似。
