In May 2025, the US Food and Drug Administration (FDA) announced the decision to grant interchangeability status to Mylan/Biocon’s biosimilar Hulio (adalimumab-fkjp). This biosimilar joins Samsung Bioepis’ Hadlima (adalimumab-bwwd), and a number of other adalimumab biosimilars, as interchangeable products available in the US market [1].
Hulio (adalimumab-fkjp) is a biosimilar of AbbVie’s Humira. Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis [2].
Granting the interchangeability designation permits pharmacists, in accordance with state laws, to substitute Hulio for Humira without requiring approval from the prescribing physician [3]. The designation is expected to broaden patient access to treatment options.
Hulio was originally launched in the US in 2023. The decision to grant Hulio this interchangeability status was based on evidence from a pivotal clinical study that demonstrated the product’s equivalence to the reference biological [4].
This randomized, double-blind trial assessed the impact of switching between reference adalimumab and biosimilar Hulio in 386 psoriasis patients. Pharmacokinetic (PK) analysis showed bioequivalence, with 90% CIs for key PK parameters within FDA limits (80–125%). Efficacy outcomes (PASI and Physician’s Global Assessment) were similar between continuous reference and switch groups. Adverse event rates were comparable (34.2% vs. 29.8%), with low discontinuations (1.0% vs. 0.6%). Immunogenicity profiles were also consistent, supporting interchangeability [4].
Other adalimumab biosimilars approved in the US, which have received interchangeability designation include: Abrilada, Cyltezo, Hadlima, Hyrimoz, Simlandi [1].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves Hadlima and Otulfi as interchangeable biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 25]. Available from: www.gabionline.net/biosimilars/news/fda-approves-hadlima-and-otulfi-as-interchangeable-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 25]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-adalimumab
3. GaBI Online - Generics and Biosimilars Initiative. What is the future for the US biosimilar interchangeability designation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 25]. Available from: www.gabionline.net/biosimilars/research/what-is-the-future-for-the-us-biosimilar-interchangeability-designation
4. Deodhar S, Longanathan S, Reddy RKS, 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. Published online June 10, 2025. doi:10.1007/s12325-025-03240-5
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