Regulatory Decision Summary for Abrilada
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):
adalimumab
Control Number:
259979
Therapeutic Area:
L04
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?
The purpose of this submission was to seek authorization of Abrilada, an adalimumab biosimilar, for the indication of pediatric ulcerative colitis, held by the reference biologic drug, Humira.
Why was the decision issued?
Abrilada (adalimumab) is a biosimilar to the reference biologic drug, Humira (adalimumab). At the time of this submission, Abrilada was authorized for the following indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, adult and adolescent hidradenitis suppurativa, plaque psoriasis, and adult and pediatric uveitis.
This Supplement to a New Drug Submission sought authorization of Abrilada for the indication of pediatric ulcerative colitis, held by the reference biologic drug, Humira. Although the indications sought in this submission have not been studied in the Abrilada clinical development programme, Health Canada’s guidance document on “Information and Submission Requirements for Biosimilar Biologic Drugs” (Revised Date: 2016-11-14) states that where similarity has been established, indications may be granted even if clinical studies are not conducted in each indication.
Biosimilarity of Abrilada to Humira was previously established in New Drug Submission Control No. 235685, based on comparative structural, functional, non-clinical, and clinical studies. Based on the totality of evidence, including the previous demonstration of biosimilarity and scientific justification for the extension of indications, the benefit-risk profile of Abrilada in the treatment of pediatric ulcerative colitis is considered to be favourable, similar with that established for Humira.
An updated Risk Management Plan (RMP) for Abrilada was reviewed by Health Canada and considered acceptable. Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable. The overall, the benefit-harm-uncertainty profile is favourable for Abrilada for the recommended indication. A Notice of Compliance (NOC) was issued.
For further details about Abrilada, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2022-11-14
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription status:
Available by prescription only
Date Filed:
2022-01-17
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ABRILADA | 02511053 | PFIZER CANADA ULC | ADALIMUMAB 40 MG / 0.8 ML |
| ABRILADA | 02511045 | PFIZER CANADA ULC | ADALIMUMAB 40 MG / 0.8 ML |
| ABRILADA | 02511096 | PFIZER CANADA ULC | ADALIMUMAB 40 MG / 0.8 ML |
| ABRILADA | 02511088 | PFIZER CANADA ULC | ADALIMUMAB 10 MG / 0.2 ML |
| ABRILADA | 02511061 | PFIZER CANADA ULC | ADALIMUMAB 20 MG / 0.4 ML |