Switch to Adalimumab Biosimilar Shows No Significant Differences for Uveitis

Se Joon Woo, MD, PhD

Credit: Seoul National University College of Medicine

A switch from adalimumab originator to SB5, an adalimumab biosimilar, did not show clinically significant differences in efficacy and safety for the treatment of patients with non-infectious uveitis, according to new research.¹

The analysis of eyes with uveitis switched from adalimumab originator to SB5 revealed no significant differences in visual acuity or macular thickness and volume in the switching period, compared with the non-switching period. Overall, the investigative team observed no recurrence of uveitis after switching to the biosimilar.

“Switching from adalimumab originator to SB5 for non-infectious uveitis does not result in clinically significant differences in treatment efficacy and safety,” wrote the investigative team, led by Se Joon Woo, MD, PhD, an associate professor of ophthalmology at the Seoul National University College of Medicine and Seoul National University Bundang Hospital.

SB5 as an adalimumab biosimilar was first approved by the US Food and Drug Administration (FDA) in July 2019 (adalimumab-bwwd) as a low-concentration (50 mg/mL) formulation of prefilled syringe and prefilled autoinjector.² A high-concentration (100 mg/mL) of adalimumab-bwwd was approved by the FDA in August 2022. The biosimilar was introduced into the commercial market in the US in July 2023.

The current analysis included a total of 15 patients, corresponding to 29 eyes, who were switched from the adalimumab originator to SB5.¹ Those patients with ≥6 months of follow-up were retrospectively included for analysis. Patient outcomes, including best-corrected visual acuity (BCVA, logMAR), intraocular pressure (IOP, mmHg), anterior chamber cell grade, anterior vitreous cell grade, vitreous haze grade, central macular thickness (µm), and macular volume (mm3), were collected at the pre-switching period and 2-, 4-, and 6-months post-switching.

Upon analysis, Woo and colleagues identified no significant differences in BCVA, anterior chamber, and anterior vitreous cell grades, and vitreous haze grades at 2-, 4-, and 6-months post-switching, compared with the pre-switching period. In addition, the investigative team found no significant differences in central macular thickness and macular volume at 2- and 6-months post-switching.

Further data revealed central macular thickness and macular volume decreased from 260.55 ± 67.44 μm and 8.37 ± 1.14 mm3 in the pre-switching period to 244.14 ± 60.31 μm (P = .032) and 8.11 ± 1.20 mm3 (P = .027), respectively, at 4 months in the post-switching period. Woo and colleagues observed no recurrence of uveitis, as defined by AC cell grade, vitreous haze, or BCVA.

Safety analyses showed four patients (27%) were switched back to the adalimumab originator after a mean of 9 weeks, owing to discomfort during the injection (n = 3) and technical difficulty with the new injection device (n = 1). There were no other data collected on adverse events related to the adalimumab to biosimilar switch.

“No other adverse events occurred after switching to SB5,” Woo and colleagues wrote.

References

1. _{Song SH, Woo SJ. Efficacy and Safety of Switching from Adalimumab Originator to SB5, Adalimumab Biosimilar for Noninfectious Uveitis. Ocul Immunol Inflamm. Published online January 9, 2024. doi:10.1080/09273948.2023.2295544}
2. _{Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMATM (adalimumab-bwwd) in Multiple Presentations Consistent with Originator. Samsung BIOEPIS. July 1, 2023. Accessed January 18, 2024. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=340&currentPage=3.}