Regulatory Decision Summary for Yuflyma

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:

Drug

Contact:

Medicinal Ingredient(s):

Adalimumab

Control Number:

281626

Brand/Product Name:

Yuflyma

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) Chemistry and Manufacturing, was submitted to request authorization for an additional dose strength of 20 mg (20 mg/0.2 mL) with identical pharmaceutical ingredients and route of administration to those of the currently authorised Yuflyma (40 mg and 80 mg).

With the approval of the 20 mg dose presentation, the sponsor was seeking authorization for pediatric Crohn’s Disease and pediatric Ulcerative Colitis. Both indications were previously not approved for Yuflyma based on the fact that the 20 mg dose was not available. The indications approved for Yuflyma are identical to the ones approved for the Canadian Reference Biologic Drug (CRBD), Humira.

Why was the decision issued?

The benefit-risk profile remains consistent with the Canadian Reference Biologic Drug (Humira), and is therefore considered favourable. The approval of the new 20 mg presentation allowed the granting of the pediatric Crohn’s disease and Ulcerative Colitis indications based on similarities with Humira.

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

Date of Decision:

2025-06-19

Manufacturer/Sponsor:

Celltrion Inc.

Drug Identification Number(s) Issued:

02556596

Prescription Status:

Schedule D drug

Date Filed:

2023-11-30

Date modified: