Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases

Adv Ther. 2024 Feb;41(2):509-533. doi: 10.1007/s12325-023-02737-1.Epub 2023 Dec 19.


Jonathan Kay 1Raymond K Cross 2Steven R Feldman 3Younjin Park 4Stephen B Hanauer 5


Author information

1Division of Rheumatology, Department of Medicine, UMass Chan Medical School, Worcester, MA, 01605, USA.

2Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.

3Department of Dermatology, Center for Dermatology Research, Wake Forest University School of Medicine, Winston-Salem, NC, 27101, USA.

4Samsung Bioepis, Incheon, Republic of Korea.

5Department of Medicine (Gastroenterology and Hepatology), Northwestern University, Chicago, IL, 60611, USA. shanauer@northwestern.edu.


SB5 is an approved biosimilar of adalimumab, a recombinant monoclonal anti-tumor necrosis factor (TNF) antibody. The approval of SB5 was based on the comparison with reference adalimumab in analytical studies, pharmacokinetic (PK) and immunogenicity assessments, and randomized controlled trials. Efficacy data was primarily obtained in patients with rheumatoid arthritis, and extended to include additional indications such as psoriasis, Crohn's disease, or ulcerative colitis by extrapolation. Following its approval, additional post-marketing data have been collected comparing SB5 with reference adalimumab. This review summarizes the clinical data on SB5 from randomized controlled trials and provides a comprehensive overview of the available post-approval data. In "real-world" settings, SB5 was as effective as its reference product across different indications and countries, treatment persistence was well maintained throughout studies, and no new safety concerns were identified. In both controlled and "real-world" settings, switching from reference adalimumab to SB5 was not associated with altered efficacy or clinical complications. In post-approval studies, the quality of SB5 was consistent over time, independent of the batch and process changes, and the SB5 autoinjector was preferred over other autoinjectors by both healthcare professionals and patients. Taken together, these data support the use of SB5 whenever reference adalimumab is appropriate and demonstrate that switching from reference adalimumab to SB5 is feasible.

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