Regulatory Decision Summary for Jamteki

The purpose of this submission was to seek market authorization for Jamteki, a proposed biosimilar to Stelara (ustekinumab). The sponsor is seeking all indications currently authorized for Stelara, based on evidence of biosimilarity. After evaluating the submitted data package, Health Canada authorized Jamteki as a biosimilar to Stelara for plaque psoriasis and psoriatic arthritis indications.

Authorization was based on the totality of the evidence presented to establish biosimilarity between Jamteki and the EU-reference product, Stelara (ustekinumab). This included studies demonstrating comparative clinical pharmacology, and clinical efficacy and safety profiles.

Comparable pharmacokinetic profiles between Jamteki, US-sourced Stelara, and EU-sourced Stelara were established in a comparative pharmacokinetic study. The phase 1 pharmacokinetic (PK) study demonstrated PK similarity following single subcutaneous administration of 45 mg ustekinumab to healthy subjects. The comparative bioavailability standards were met.

The confirmatory clinical study was a phase 3, multicenter, randomized, double-blind trial in patients with moderate-to-severe plaque psoriasis. The primary endpoint was the percent improvement from baseline to Week 12 in Psoriasis Area and Severity Index (PASI). The difference in the PASI response rate at week 12 for Jamteki was compared to that for EU-Stelara and was found to be within a predefined equivalence margin to establish clinical comparability. There were no clinically meaningful differences in the efficacy and safety of Jamteki to EU-Stelara. The totality of the clinical evidence, including clinical pharmacokinetic, efficacy and safety comparisons, provides adequate evidence to establish clinical biosimilarity between Jamteki and Stelara.

As a biosimilar to Stelara, Jamteki has demonstrated a comparable benefit/risk profile for the treatment of adult plaque psoriasis, based on the evidence provided in this submission. Additionally, based on the scientific justification and the sponsor’s rationale, this favourable profile is extended to the psoriatic arthritis indication currently authorized for the Canadian reference product in line with relevant guidelines. Overall, the benefit/risk profile of Jamteki is considered favourable and consistent with that of Stelara for both of these indications.

Health Canada has not authorized the Crohn’s disease, Ulcerative Colitis, and pediatric plaque psoriasis indications because the sponsor has not included vial presentations within this submission.