Regulatory Decision Summary for Remsima SC

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

Medicinal ingredient(s):

Infliximab

Therapeutic area:

Immunosuppressants

Type of submission:

Supplement to a New Drug Submission

Control number:

262141
What was the purpose of this submission?

The purpose of this Supplement to a New Drug Submission (SNDS) was to seek authorization of an alternative loading posology of 120 mg Remsima SC at weeks 0, 1, 2, 3, and 4 followed by a maintenance therapy of 120 mg Remsima SC Q2W in adult patients with moderate to severe rheumatoid arthritis.

Why was the decision issued?

Authorization was based on pharmacometrics approaches involving pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation. No new clinical studies were conducted with the proposed new posology.

The sponsor tested different scenarios that were compared to the currently approved Remsima posology to identify the optimal dosing regimen of Remsima administered subcutaneously in patients with rheumatoid arthritis. The proposed new dosing regimen displayed the closest similarity to the currently approved Remsima posology based on the serum concentration of the drug at Week 4, its Cthrough level and exposure over the first 14 weeks. Based on simulations, the efficacy of Remsima SC (i.e., DAS28 scores) has also been demonstrated to be comparable to that of Remsima IV in RA patients until Week 30. Given that the overall PK exposure and Ctrough levels of the new dosing regimen were similar to the approved Remsima IV dosing regimen, no significant difference in safety profile is expected. Based on the totality of the data, the Remsima SC program supports the conclusion that the proposed dosing regimen of 120 mg Remsima SC at weeks 0, 1, 2, 3, and 4 followed by a maintenance therapy of 120 mg Remsima SC Q2W has a favourable benefit-risk profile, and it is thus recommended as a new alternative dosing regimen in adults with moderate to severe rheumatoid arthritis.

Decision issued

Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.