title: Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab).
abstract: A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration. To determine whether critical quality attributes meet quality standards, an extensive characterization test was performed with more than 80 lots of EU- and US-sourced RP. The physicochemical characterization study results revealed that SB2 was similar to the RP. Although a few differences in physicochemical attributes were observed, the evidence from the related literature, structure-activity relationship studies, and comparative biological assays showed that these differences were unlikely to be clinically meaningful. The biological characterization results showed that SB2 was similar to the RP in terms of tumor necrosis factor-α (TNF-α) binding and TNF-α neutralization activities as a main mode of action. SB2 was also similar in Fc-related biological activities including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, neonatal Fc receptor binding, C1q binding, and Fc gamma receptor binding activities. These analytical findings support that SB2 is similar to the RP and also provide confidence of biosimilarity in terms of clinical safety and efficacy.
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Juyong
authors.initials: J
authors.lastname: Hong
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Yuhwa
authors.initials: Y
authors.lastname: Lee
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Changsoo
authors.initials: C
authors.lastname: Lee
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Suhyeon
authors.initials: S
authors.lastname: Eo
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Soyeon
authors.initials: S
authors.lastname: Kim
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Nayoung
authors.initials: N
authors.lastname: Lee
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Jongmin
authors.initials: J
authors.lastname: Park
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Seungkyu
authors.initials: S
authors.lastname: Park
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Donghyuck
authors.initials: D
authors.lastname: Seo
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Min
authors.initials: M
authors.lastname: Jeong
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Youngji
authors.initials: Y
authors.lastname: Lee
authors.affiliation: a Quality Evaluation Team, Samsung Bioepis Co., Ltd , Incheon , South Korea.
authors.forename: Soojeong
authors.initials: S
authors.lastname: Yeon
authors.affiliation: b Department of Analytical Development , Biogen, Inc. , Cambridge , MA , USA.
authors.forename: George
authors.initials: G
authors.lastname: Bou-Assaf
authors.affiliation: b Department of Analytical Development , Biogen, Inc. , Cambridge , MA , USA.
authors.forename: Zoran
authors.initials: Z
authors.lastname: Sosic
authors.affiliation: b Department of Analytical Development , Biogen, Inc. , Cambridge , MA , USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: c Department of Medical Affairs , Biosimilars , Biogen , Zug , Switzerland.
authors.forename: Orlando
authors.initials: O
authors.lastname: Jaquez
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry* / Q000494:pharmacology*; D006801:Humans; D000069285:Infliximab / Q000737:chemistry* / Q000494:pharmacology*
chemical_list: D059451:Biosimilar Pharmaceuticals; D000069285:Infliximab
keywords: Biosimilar; SB2; critical quality attribute; flixabi; infliximab; renflexis