Regulatory Decision Summary for Otulfi (ustekinumab)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal Ingredient(s):
ustekinumab
Control Number:
296870
Brand/Product Name:
Otulfi
Therapeutic Area:
Immunosuppressants
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) for the biosimilar product Otulfi (ustekinumab) was filed to seek approval for a new vial presentation (45 mg/0.5 mL vial for subcutaneous injection) and to expand the moderate to severe plaque psoriasis indication to the pediatric population, in accordance with the indications granted to the Canadian Reference Biologic Drug, Stelara.
Why was the decision issued?
No additional clinical studies were conducted nor was any clinical data supplied to support the new indication. The rationale for expanding indications to indications granted to the reference product is based on the critical attributes and similarity of the products and remains a valid rationale to grant the pediatric psoriasis indication.
The benefit-risk profile remains consistent with the Canadian Reference Biologic Drug, and is therefore considered favourable.
The Risk Management Plan (RMP) for Otulfi was reviewed by Health Canada and considered acceptable, as they are in alignment with the RMP for the Canadian Reference Biologic Drug, Stelara.
The chemistry and manufacturing information submitted for Otulfi 45 mg/0.5 mL vial has demonstrated that the drug product can be consistently manufactured to meet the authorized specifications.
The labelling material submitted met all applicable regulations and guidance.
For further details about Otulfi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2026-02-02
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02565420
Prescription Status:
Prescription and Schedule D drug
Date Filed:
2025-04-07
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| OTULFI | 02554283 | FRESENIUS KABI CANADA LTD | USTEKINUMAB 45 MG / 0.5 ML |
| OTULFI | 02565420 | FRESENIUS KABI CANADA LTD | USTEKINUMAB 45 MG / 0.5 ML |
| OTULFI | 02554291 | FRESENIUS KABI CANADA LTD | USTEKINUMAB 90 MG / ML |