Regulatory Decision Summary for Steqeyma, Steqeyma I.V.

The purpose of this Supplement to a New Drug Submission (SNDS) was to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Steqeyma, Steqeyma I.V. (ustekinumab), filed by Celltrion Inc.

This Supplement was filed for Steqeyma/Steqeyma I.V. (ustekinumab), a biosimilar to Stelara, for a new indication. Upon review of the submitted data package, Health Canada authorized Steqeyma, Steqeyma I.V. with the following indication: Steqeyma, Steqeyma I.V. (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Steqeyma. is a biosimilar to Stelara, the Canadian Reference Biologic Drug (CRBD), therefore, the benefit-risk assessment for these indications, including the new ulcerative colitis indication, was supported by the biosimilarity assessment previously conducted at the time of initial approval and the clinical studies conducted with the CRBD (i.e., Stelara).

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Steqeyma, Steqeyma I.V. (45mg/0.5mL, 5mg/mL and 90mg/mL) for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Steqeyma, Steqeyma I.V., please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.