Regulatory Decision Summary for Avsola
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.
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What was the purpose of this submission?
The purpose of this submission was to seek market authorization for Avsola, a proposed biosimilar to the Canadian reference product Remicade (infliximab). The sponsor was seeking indications authorized for Avsola based on the evidence of biosimilarity derived from comparative structural, functional, non-clinical, and clinical studies relative to the reference product. After evaluation of the submitted data package, Health Canada authorized Avsola as a biosimilar to the Canadian reference product for all currently authorized indications for infliximab. The authorized indications include rheumatoid arthritis, ankylosing spondylitis, Crohns Disease (adult and pediatric), ulcerative colitis (adult and pediatric), plaque psoriasis and psoriatic arthritis as listed in the product monograph.
Why was the decision issued?
Authorization was based on the totality of evidence presented to establish biosimilarity between Avsola and Remicade (infliximab). This included studies demonstrating Quality aspects of comparative structural and functional attributes, nonclinical aspects, as well as clinical pharmacokinetic, efficacy, and safety parameters. Clinical studies included a comparative pharmacokinetic study evaluating Avsola against infliximab as well as a pivotal phase 3, multicenter, randomized, double-blind study in patients with moderate-to-severe rheumatoid arthritis.
Based on the assessment of the data provided in the pivotal study, the safety, efficacy and immunogenicity of Avsola were comparable to the infliximab arm with no new signals or significant imbalances between groups. The most common adverse events reported in the pivotal clinical study were comparable to the reference product and included: upper respiratory tract infection, pharyngitis and erythema. Avsola was comparable to the reference infliximab with respect to the formation of anti-drug antibodies and neutralizing antibodies.
As a biosimilar to the Canadian reference infliximab, Avsola has a comparable and favourable benefit/risk profile in the management of moderate-to-severe rheumatoid arthritis. The scientific rationale provided by the sponsor in addition to the data presented to establish biosimilarity, to support the authorization of Avsola in each indication held by the reference biologic drug is considered acceptable, and a favourable benefit/risk profile is concluded for the authorized indications.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| AVSOLA | 02496933 | AMGEN CANADA INC | INFLIXIMAB 100 MG / VIAL |