Regulatory Decision Summary for Hulio

Hulio (adalimumab) is a proposed biosimilar to the drug Humira, which has been marketed in Canada since 2004. Humira is indicated for a number of autoimmune and inflammatory conditions in pediatric and adult patients, including rheumatoid arthritis (RA), psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohns disease, ulcerative colitis, hidradenitis suppurativa, uveitis, and polyarticular juvenile idiopathic arthritis. Hulio will be the third Humira biosimilar marketed in Canada.

A comparable pharmacokinetic profile between Hulio and United States-sourced Humira was established in a comparative pharmacokinetic study conducted in healthy subjects. Comparable efficacy, safety and immunogenicity between the two products were also demonstrated in a randomized, double-blind, controlled study. Patients with moderate to severe RA were treated for a primary analysis period of 24 weeks with either Hulio (FKB) or United States-sourced Humira (HUM). The primary endpoint of equivalence in ACR20 response rate at Week 24 was achieved, based on pre-specified equivalence margins. The safety of Hulio was assessed using both the pivotal efficacy trial and an open-label extension of that trial. Numerical differences in some adverse events were reported between Hulio and Humira in the clinical studies, but they were not considered to be clinically meaningful.

Based on the clinical pharmacology, efficacy, immunogenicity, and safety data presented in the Phase 1 bioequivalence trial and the Phase 3 efficacy trials (ARABESC and its open-label extension trial), similarity between the test product (Hulio) and the reference product (Humira) has been demonstrated. There were no areas where discrepancies between groups were of substantial magnitude or consistency to indicate clinically meaningful differences. The similarities between these two products demonstrated throughout the submission package, in addition to rationales submitted by the Sponsor, are supportive of expansion of the indications to all currently-authorized Humira indications, including those for pediatric patients.