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Comparative Study
. 2025 Mar 18;192(4):641-652.
doi: 10.1093/bjd/ljae454.

Drug survival and safety of biosimilars for treating psoriasis compared with originator adalimumab: a multinational cohort study

Duc Binh Phan  1 , Hugo Jourdain  2 , Miguel Angel Descalzo-Gallego  3 , Alicia González-Quesada  4 , Mahmoud Zureik  2 , Raquel Rivera-Díaz  5 , Antonio Sahuquillo-Torralba  6 , Mark Lunt  7 , Ignacio Garcia-Doval  3   8 , Emilie Sbidian  2   9 , Richard B Warren  1 , Zenas Z N Yiu  1
Affiliations
Comparative Study

Drug survival and safety of biosimilars for treating psoriasis compared with originator adalimumab: a multinational cohort study

Duc Binh Phan et al. Br J Dermatol. .

Abstract

Background: The lack of evidence from routine clinical settings has limited the widespread adoption of adalimumab biosimilars for the treatment of psoriasis.

Objectives: To compare the drug survival and safety of adalimumab biosimilars with Humira® in psoriasis.

Methods: We conducted a prevalent new-user cohort study using data from the French National Health Data System (SNDS), the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) and the Spanish Registry of Systemic Therapy in Psoriasis (BIOBADADERM). Adalimumab-naïve patients initiating adalimumab biosimilars (new users) were compared with Humira new users. Patients switching from Humira to biosimilars (switchers) were compared with those who continued Humira treatment. Patients were matched 1 : 1 based on previous adalimumab exposure time to create equal-sized cohorts of biosimilar and Humira users. Co-primary outcomes included drug discontinuation and serious adverse events (SAEs). Hazard ratios (HRs) were calculated using Cox proportional hazard models. Meta-analyses using random-effect models were performed to combine results from the three databases.

Results: In total, 7387 biosimilar new users and 3654 switchers were matched and compared with Humira users. No differences in all-cause discontinuation were found between biosimilar and Humira new users [HR 0.99, 95% confidence interval (CI) 0.94-1.04]. Switching from Humira to biosimilars was associated with a higher discontinuation rate than remaining on Humira (HR 1.35, 95% CI 1.19-1.52). Similar results were observed for discontinuation due to ineffectiveness or adverse events. Risks of SAEs were similar between biosimilar new users and Humira new users [incidence rate ratio (IRR) 0.91, 95% CI 0.80-1.05] or between switchers and continuous Humira users (IRR 0.92, 95% CI 0.83-1.01).

Conclusions: Adalimumab biosimilars can be considered viable alternatives to Humira for new patients, with comparable effectiveness and safety. However, owing to the higher likelihood of discontinuation, patients who switch from Humira to biosimilars may require closer monitoring and support.

Plain language summary

Psoriasis is a long-term inflammatory skin disease that affects over 60 million people globally. Adalimumab is a drug often used to treat moderate to severe psoriasis. The original adalimumab brand (called Humira®) is expensive and adds pressure to health care systems. ‘Biosimilars’ are drugs that are similar to Humira. They became available in Europe in 2018. These drugs could help cut costs and make treatment more accessible. This study looked at how long people stayed on treatment. It also looked at the safety of adalimumab biosimilars in people with psoriasis. Information from large health databases in France, the UK and Spain was used to compare two groups. The first group included people who started on either biosimilars or Humira for the first time. The second included people who switched from Humira to biosimilars compared with those who kept taking Humira. There was no difference in how long new users of biosimilars stayed on treatment compared with new users of Humira. Patients who switched from Humira to biosimilars were more likely to stop treatment than those who kept using Humira. The risk of serious side effects was similar for both biosimilar and Humira users. Our findings suggest that biosimilars are as safe and effective as Humira. Patients who switch to biosimilars from Humira are more likely to stop treatment. More research is needed to understand the effects of switching.

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