Regulatory Decision Summary for Hyrimoz
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:
272451
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 Supplement to a New Drug Submission (SNDS) was to seek authorization for Hyrimoz – High-Concentration Formulation (HCF) 100 mg/mL with 20 mg/0.2 mL, 40 mg/0.4 mL, and 80 mg/0.8 mL presentations for the same approved indications and dose regimens currently authorized for Hyrimoz – Low-Concentration Formulation (LCF) 50 mg/mL.
Why was the decision issued?
Authorization of the proposed Hyrimoz-HCF dosage form through this SNDS was based on one randomized, double-blind, parallel, single-dose study that compared the pharmacokinetic (PK), safety, and immunogenicity of the HCF with the currently authorised LCF, in healthy subjects following a single 40 mg subcutaneously administration. Pharmacokinetic results of the relative bioavailability from 300 subjects demonstrated bioequivalence based on the geometric mean ratios (GMRs) of maximum observed serum drug concentration (Cmax), area under curve from time zero to the last measurable concentration sampling time (AUC0-last) and area under curve from time zero to infinity (AUC0-inf). The 90% confidence intervals (CIs) of the ratios (HCF/LCF) of point estimates for Cmax, AUC0-last and AUC0-inf were all within pre-defined bioequivalence limits of 80 – 125%. No clinically meaningful differences in terms safety and immunogenicity were observed between the HCF and LCF treatment groups.
The recommended dose of the drug is the same as currently labelled for Hyrimoz. View the Product Monograph (PM) for details.
An updated Risk Management Plan (RMP) for Hyrimoz 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 benefit-risk profile of the new proposed HCF is deemed the same as the currently authorized LCF and is therefore considered positive. The final decision for this product was based on the totality of evidence, including pharmacokinetic (PK) and clinical comparisons between the two formulations (HCF vs. LCF).
The chemistry and manufacturing information submitted for Hyrimoz has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.
For further details about Hyrimoz, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2023-10-13
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
02542366
02542358
02542331
02542323
02542315
Prescription status:
Available by prescription only
Date Filed:
2023-02-27
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| HYRIMOZ | 02542366 | SANDOZ CANADA INCORPORATED | ADALIMUMAB 80 MG / 0.8 ML |
| HYRIMOZ | 02542331 | SANDOZ CANADA INCORPORATED | ADALIMUMAB 40 MG / 0.4 ML |
| HYRIMOZ | 02542358 | SANDOZ CANADA INCORPORATED | ADALIMUMAB 80 MG / 0.8 ML |
| HYRIMOZ | 02542323 | SANDOZ CANADA INCORPORATED | ADALIMUMAB 40 MG / 0.4 ML |
| HYRIMOZ | 02542315 | SANDOZ CANADA INCORPORATED | ADALIMUMAB 20 MG / 0.2 ML |