adalimumab (Handayuan / Handafar / adalimumab, Henlius)

Originator versus biosimilar adalimumab in hidradenitis suppurativa: a real-world cohort study.

Demirbaş Abdullah A, Esen Mustafa M, Diremsizoğlu Esin E, Ulutaş Demirbaş Gözde G

Comparative real-world data on originator and biosimilar adalimumab in hidradenitis suppurativa (HS) are limited. We compared effectiveness, persistence, and safety of originator (ADL-O) versus three biosimilars (ADL-B1, ADL-B2, ADL-B3) in routine care. Retrospective cohort of 146 biologic-naive HS patients initiating adalimumab (January 2020-November 2025) at three tertiary centers in Turkiye. Primary outcomes were Week-12 HiSCR50 and IHS4-55 responses, compared using overlap weighting. Persistence was assessed by 24-week restricted mean survival time (RMST). Safety was summarized descriptively. Baseline characteristics were well balanced across groups. Overlap-weighted Week-12 analyses excluding the ADL-B3 evaluable subset (n = 118) showed no evidence of differential effectiveness: HiSCR50 RR 1.05 (95% CI 0.78-1.42); IHS4-55 RR 1.07 (95% CI 0.76-1.52). Inclusion of ADL-B3 as a sensitivity analysis did not alter the findings. Among Week-52 evaluable ADL-O and ADL-B1 patients, HiSCR50 was 68.8% in both groups. Product-level 24-week RMST was 23.4 versus 22.3 weeks (difference -1.1 weeks, 95% CI - 2.7 to 0.5). Safety comparisons were descriptive given limited sample size. No statistically significant difference in short-term effectiveness was detected between originator and biosimilar adalimumab in HS. The findings reflect absence of evidence for a difference rather than equivalence. Larger prospective studies with immunogenicity assessment are needed.

Increasing formulary adoption of adalimumab biosimilars and differential cost-sharing in Medicare Part D plans.

Feng Alina S AS, Liao Wilson W

Adalimumab was among the first biologics to face widespread biosimilar competition following US market entry of multiple adalimumab biosimilars in 2023. However, Medicare Part D formulary adoption of these products and their associated specialty-tier cost-sharing requirements remain unknown. To evaluate adalimumab biosimilar adoption and associated cost-sharing patterns across Medicare Part D formularies, Centers for Medicare & Medicaid Services (CMS) Medicare Part D Formulary and Plan Benefit Package files were analyzed. Plans were categorized as covering originator adalimumab-only, both originator and biosimilar products (dual coverage), or biosimilars-only. In 2023, all Medicare Part D plans covering adalimumab listed only the originator product. By 2024, 52.5% of plans provided dual coverage, increasing to 79.9% in 2025. Biosimilar-exclusive coverage increased from 8.6% of plans in 2025 to 45.9% in 2026, while originator-only coverage declined to 0.8%. Median specialty-tier coinsurance differed according to coverage strategy. In 2026, median specialty-tier coinsurance was 33% among originator-only plans, 27% among dual-coverage plans, and 25% among biosimilar-only plans. Medicare Part D formularies rapidly included adalimumab biosimilars following market entry, with substantial growth in biosimilar-exclusive coverage by 2026. Specialty tier coinsurance varied by medication coverage type, suggesting that evolving formulary strategies may influence beneficiary cost-sharing requirements.

Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study.

Vuijk Stephanie A SA, Klomberg Renz C W RCW, Katgert Eva E, Wessels Margreet M S MMS et al.

Infliximab and adalimumab are effective anti-tumor necrosis factor (anti-TNF) therapies for the treatment of pediatric Crohn's disease (CD). The aim of this study was to compare the effectiveness of infliximab and adalimumab in a real-world cohort of children with CD. Data from biological-naïve children with luminal CD (age 3-18 years) who commenced anti-TNF and completed at least 1 year of follow-up were collected from the prospective multicenter observational PIBD-SETQuality study. The primary outcome was steroid-free clinical remission (SFCR), defined as clinical remission (weighted pediatric Crohn's disease activity index [wPCDAI] <12.5) without systemic steroids or luminal surgery at 1 year. The relative risk (RR) of SFCR was calculated using standardization, correcting for the following baseline covariates: age, upfront anti-TNF, C-reactive protein, erythrocyte sedimentation rate, albumin, leukocytes, disease behavior, wPCDAI, perianal disease, and concomitant immunomodulator use. Secondary outcomes included the durability of anti-TNF treatment without luminal surgery. Between January 1, 2017, and June 14, 2024, 178 patients with anti-TNF were included (infliximab: n = 121 [68%], adalimumab: n = 57 [32%]). At 12 months, 34/56 (61%) patients treated with adalimumab and 66/120 (55%) patients treated with infliximab had reached SFCR. The RR of SFCR at 1 year with adalimumab compared to infliximab was 1.25 (95% confidence interval [CI] 0.94-1.66], P = .13. Adalimumab was associated with a significant lower adjusted hazard ratio (aHR) of treatment discontinuation than infliximab in patients with a concomitant immunomodulator (aHR 0.17 [95% CI 0.04-0.75], P = .020), adjusted for upfront anti-TNF. In this prospective cohort of children with CD, adalimumab and infliximab showed comparable clinical effectiveness 1 year after the start of anti-TNF treatment. The ClincalTrials.gov ID of this study is NCT03571373.

Pregnancy Outcome in a Patient With DADA2 Syndrome on Continued Adalimumab Therapy.

Pridhivi Bhargavi B, Naidu Gsrsnk G, Bhatia Prateek P, Lee Pui Y PY et al.