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Switching between adalimumab and biosimilar adalimumab-atto shows similar pharmacokinetics in plaque psoriasisSwitching between adalimumab and its biosimilar is safe and similar

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Key Takeaway
Consider that switching between adalimumab and its biosimilar adalimumab-atto yields similar pharmacokinetics, supporting interchangeability.

This phase 3, multicenter RCT (85 centers) enrolled 425 adults with moderate-to-severe plaque psoriasis to evaluate pharmacokinetic similarity after multiple switches between adalimumab RP and its biosimilar adalimumab-atto (ABP 501). Patients received a 12-week lead-in with adalimumab RP, followed by a 16-week double-blind period where they were randomized to either continue adalimumab RP or undergo multiple switches between the two products. The primary outcome was pharmacokinetic similarity, assessed by AUC and Cmax between weeks 28 and 30. The ratio of geometric least squares means (continued-use vs switching) for AUC was 1.0516 (90% CI: 0.9010, 1.2273) and for Cmax was 1.0044 (90% CI: 0.8717, 1.1574), both within the prespecified equivalence margin of 0.8-1.25. No new or concerning safety signals were observed, and discontinuation rates were similar between groups. However, the study does not provide detailed comparative efficacy or long-term safety data beyond the 28-week follow-up. These results support the interchangeability designation of ABP 501 with adalimumab RP, but clinicians should note that clinical equivalence beyond pharmacokinetics was not established.

For people with moderate-to-severe plaque psoriasis, sticking with the same biologic drug has been the standard. But a new study suggests that switching between the original adalimumab (Humira) and its biosimilar version, adalimumab-atto, may be just as good.

The trial involved 425 adults across 85 centers. Some patients continued using the original adalimumab, while others switched back and forth between the original and the biosimilar. The researchers measured drug levels in the blood and found that the two groups had very similar concentrations. The ratios for both AUC and Cmax fell within the predefined range (0.8 to 1.25), meaning the drugs behaved similarly in the body.

Safety was also comparable. No new or concerning side effects emerged, and the number of people who stopped treatment was similar between groups. The study lasted 28 weeks, with a 12-week lead-in and a 16-week double-blind period.

While these results support the idea that adalimumab-atto can be used interchangeably with the original, the study focused on drug levels, not long-term clinical outcomes. More research is needed to confirm that switching doesn't affect how well the drug works over time.

What this means for you:
Switching between adalimumab and its biosimilar adalimumab-atto appears safe and produces similar drug levels.

Study Details

Study typeRct
Sample sizen = 425
EvidenceLevel 2
Follow-up2.8 mo
PublishedJun 2026
View Original Abstract ↓
INTRODUCTION: ABP 501, now approved as AMJEVITA (adalimumab-atto, USA)/AMGEVITA (adalimumab, EU), is a biosimilar to adalimumab reference product (RP, Humira) indicated for the treatment of various chronic inflammatory conditions. This multicenter, randomized, double-blind study aimed to investigate the impact of multiple switches between adalimumab RP and ABP 501 as compared with continued-use of adalimumab RP. METHODS: This study (NCT05073315) consisted of a 12-week lead-in period where adults with moderate-to-severe plaque psoriasis received adalimumab RP subcutaneously every 2 weeks (Q2W), followed by a double-blind, two-parallel arm period in which patients were randomized to either the continued-use group (adalimumab RP Q2W, weeks 12-28) or switching group (ABP 501, weeks 12 and 14; adalimumab RP, weeks 16 and 18; ABP 501 Q2W, weeks 20-28). The primary pharmacokinetic (PK) endpoints were area under the serum concentration-time curve (AUC) and maximum observed serum concentration (C) between weeks 28 and 30. Secondary endpoints included additional PK assessments and measures of safety, immunogenicity, and efficacy. RESULTS: A total of 425 patients were enrolled across 85 centers. Adherence to dosing protocol and completion/discontinuation rates were similar between groups. The ratio of geometric least squares means (90% confidence interval; CI) between the continued-use group and switching group for AUC was 1.0516 (0.9010, 1.2273) and for C was 1.0044 (0.8717, 1.1574); 90% CIs were contained within the prespecified similarity margin (0.8, 1.25). Secondary endpoints were comparable between groups. There were no new or concerning safety signals. CONCLUSION: This study demonstrates PK similarity in patients with plaque psoriasis who underwent three treatment switches between adalimumab RP and ABP 501 as compared with those who received continuous treatment with adalimumab RP. Safety, immunogenicity, and efficacy profiles were comparable. Overall, results support the interchangeability designation of ABP 501 with adalimumab RP, consistent with the US Food and Drug Administration (2019) guidelines. TRIAL REGISTRATION: This study was registered as NCT05073315.
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