Regulatory Decision Summary for Idacio

Authorization was based on the totality of evidence presented to establish biosimilarity between Idacio and the reference product, Humira. This included studies demonstrating comparative non-clinical and clinical safety and efficacy as well as comparable pharmacokinetics to the comparator.

In the pivotal comparative pharmacokinetic trial, pharmacokinetic comparability was demonstrated between Idacio and its comparator product Humira according to the established criteria for demonstrating biosimilarity as stated in Health Canadas guidance documents.

In a double-blind Phase 3 safety and efficacy trial in adult patients with plaque psoriasis, clinical efficacy was achieved by similar proportions of patients in each treatment group, and the difference between the Idacio and Humira arms fell within the pre-specified equivalence margins for clinical bioequivalence. The safety profiles of Idacio and Humira were similar and consistent with the established safety profile for Humira.

The totality of evidence, including structural, functional, non-clinical, pharmacokinetic and clinical efficacy and safety comparisons, provided adequate evidence to establish clinical biosimilarity between Idacio and Humira. The favourable benefit-risk profile demonstrated in clinical studies performed in adult patients with plaque psoriasis is extended to other indications currently authorized for the reference product and sought by the sponsor based on scientific rationale in line with relevant guidelines such as "Information and Submission requirements for Biosimilar Biologic Drugs".

For more information on Health Canadas decision, please view the Summary Basis of Decision.