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

Summary

Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved and United States (US)-Licensed Humira. This is a multicenter, randomized blinded, parallel group, interchangeability study in subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and, Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product. The study will also assess safety, efficacy and immunogenicity between these two groups.

Timeline

Start

2022-11-21

Primary completion

2023-09-19

Completion

2023-09-19

Publications

• Deodhar S, Loganathan S, Kadadanamari Subbarama Reddy R, Ranganna GM, Liu S, Hummel MA, Daniluk S, Hanczewska A, Vekovska K, Zegadlo-Mylik M, Pulka G, -Holz EW. 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 Aug;42(8):3795-3809. doi: 10.1007/s12325-025-03240-5. Epub 2025 Jun 10.

Drugs

Indications