Regulatory Decision Summary for Hyrimoz

Hyrimoz was previously evaluated and based on the totality of evidence provided to Health Canada, found to have no meaningful differences to the Canadian reference, Humira. At the time of initial filing as a biosimilar to Humira, Sandoz Canada Inc., was requested to remove certain indications that could not be adequately maintained or dosed with Hyrimoz. For juvenile idiopathic arthritis, this was due to the unavailability of a suitable presentation for patients weighing less than 30 kg and requiring a 20 mg dose. A precautionary statement was included to limit dosing errors in this population. Consequently, with the new presentation in the current submission, the 20 mg maintenance dose became available for pediatric patients weighing less than 30 kg. This required revisions to the product monograph as the new presentation was labelled, revisions to remove previously added precautionary statements were also required. These revisions are not expected to influence the benefit risk profile of Hyrimoz. Overall, the benefit risk profile of Hyrimoz is comparable to Humira and remains favourable for the authorized indications.

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