Study Confirms Interchangeability of Hulio, Biosimilar of Humira, in Severe Chronic Plaque Psoriasis

Key Takeaways

Hulio and Humira showed similar pharmacokinetics, efficacy, safety, and immunogenicity in severe chronic plaque psoriasis, supporting Hulio's FDA interchangeability status.
A phase 3 trial confirmed pharmacokinetic equivalence between Hulio and Humira through repeated switching, with comparable PASI scores and TEAEs.
Despite limited diversity in the study population, Hulio is expected to produce the same clinical results as Humira when administered at dose parity.

Hulio shows comparable efficacy and safety to Humira in treating chronic plaque psoriasis, supporting its FDA interchangeability status.

Adalimumab-fkjp (Hulio; Biocon Biologics, Inc) had similar pharmacokinetics, efficacy, safety, and immunogenicity profiles compared to its reference product, Humira (adalimumab; AbbVie), in patients with severe chronic plaque psoriasis, according to new data. The authors noted that these results support the FDA-granted interchangeability status of Hulio.¹

Image credit: luchschenF | stock.adobe.com

About the Trial

Trial Name: Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity

ClinicalTrials.gov ID: NCT05637515

Sponsor: Biocon Biologics Inc.

Completion Date: September 19, 2023

Adalimumab is a fully human, recombinant monoclonal antibody that inhibits the binding of tumor necrosis factor-alpha to its receptor, affecting both the soluble and membrane-bound forms. It is used to treat various autoimmune conditions, such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Adalimumab received its initial approval from the FDA for the treatment of rheumatoid arthritis.²

In a multicenter, randomized, blinded, parallel-group, interchangeability phase 3 clinical trial (NCT05637515), patients with moderate to severe chronic plaque psoriasis underwent repeated switches between Hulio and Humira to confirm the pharmacokinetic equivalence of alternating between the 2 treatments.³ The trial’s primary objective was to evaluate the interchangeability of low-concentration Hulio (40 mg/0.8 mL) with high-concentration Humira (40 mg/0.4 mL) by comparing adalimumab steady-state pharmacokinetics between switching and non-switching arms. Patients were enrolled from 31 sites across 4 countries between December 5, 2022, and September 19, 2023.^1,3

Patients received 80 mg of Humira during week 1, followed by 40 mg biweekly during weeks 2 to 10. Patients who achieved a Psoriasis Area and Severity Index (PASI) 50 response at week 12 or visit 7 were randomly assigned to the following 2 groups for further treatment: 40 mg of Humira biweekly, administered during weeks 12 through 26 (nonswitch arm); and 40 mg of Hulio administered during weeks 12 and 14, then 40 mg of Humira during weeks 16 and 18, followed by 40 mg of Hulio on weeks 20, 22, 24, and 26 (switch arm). The last dose in the switch arm was at week 26, and the follow-up safety assessments were carried out 4 weeks following the final dose, with the last efficacy and PK assessments carried out at week 28.¹

At week 28, the mean PASI total scores were about 1.64 in both the nonswitch and switch arms, and the mean changes from the baseline were similar (−19.86 vs −19.59, respectively). Improvements of the PASI scores from the baseline were approximately 91.7% in those who did not switch and 91.8% in those who did. Overall, the mean PASI total score, mean change from baseline, and percent improvement in PASI scores from baseline over time were comparable between the 2 arms, wrote the study authors. Additionally, the proportion of patients with a PASI 75, PASI 90, and PASI 100 response at week 28 was comparable between the 2 treatment arms.¹

Overall, there were no safety concerns that were related to the Hulio. A total of 241 treatment-emergent adverse events (TEAEs) were reported in 32.1% (n = 120) of patients across both arms. The incidence of TEAEs were similar between the treatment arms, with 34.2% (n = 66) of those in the nonswitch group reporting a total of 139 TEAEs and 29.8% (n = 54) of patients in the switch arm reporting a total of 102 TEAEs. TEAEs that led to treatment discontinuation were similar across the groups, with a total of 3 events across both groups (nonswitch: 2 TEAEs, 2 patients; switch: 1 TEAE in 1 patient).¹

The authors acknowledged that a potential limitation of this study is the lack of diversity among the study populations, with the vast majority (99.5%) of participants being White from Eastern European countries. Despite this, the investigators reported that the treatment arms were balanced, therefore, ethnicity among the groups should not have any impact on treatment outcomes.¹

With these data, Hulio can be expected to produce the same clinical results as its reference product, Humira, when administered at dose parity.¹

“The results of this study support the interchangeability status recently granted by FDA for [Hulio] in order to be used interchangeably with [Humira] for chronic plaque psoriasis and other indications,” the authors wrote.¹

REFERENCES

1. Deodhar S, Loganathan S, Kadadanamari Subbarama Reddy R, et al. Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability. Adv Ther (2025). doi:10.1007/s12325-025-03240-5

2. National Library of Medicine — National Center for Biotechnology Information. Adalimumab. Updated November 12, 2023. Accessed June 18, 2025. https://www.ncbi.nlm.nih.gov/books/NBK557889/

3. Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity. ClinicalTrials.gov identifier: NCT05637515. Updated October 22, 2024. Accessed June 18, 2025. https://clinicaltrials.gov/study/NCT05637515

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