Regulatory Decision Summary for HADLIMA, HADLIMA PushTouch
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.
Type of submission:
What was the purpose of this submission?
Samsung Bioepis Co. Ltd filed two submissions to seek marketing authorization of Hadlima and Hadlima PushTouch, as biosimilars to Humira, the reference biological drug in Canada, on the basis of comparative quality, non-clinical, pharmacokinetic and clinical efficacy and safety studies. Hadlima and Hadlima PushTouch have an identical formulation and differ only in the device for subcutaneous injection (pre-filled syringe for Hadlima vs. auto-injector for Hadlima PushTouch). One submission was filled for both products to seek the following indications: rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), plaque psoriasis (Ps), uveitis and polyarticular juvenile idiopathic arthritis (pJIA, patients >4 years of age and who require a full 40 mg dose). The second submission includes the indications in the first submission and also seeks three additional indications: ulcerative colitis (UC), adult Crohns disease (CD) and hidradenitis suppurativa (HS). All these indications are currently authorized for Humira in Canada.
Why was the decision issued?
Comparable pharmacokinetics between Hadlima and Humira was established in a comparative pharmacokinetic study conducted in healthy subjects as the results showed that the point estimate for the Hadlima and Humira geometric least square mean ratio for Cmax and the 90% CI for the AUCT were within the equivalence margins of 80.0% to 125.0%. Comparable efficacy, safety and immunogenicity between the two products were also demonstrated in a randomized, double-blind, controlled study conducted in adult patients with moderate to severe rheumatoid arthritis (RA) despite treatment with methotrexate. The estimated treatment difference in the ACR20 response rates at Week 24 between Hadlima and Humira treatment groups was 0.8% (95% CI: -7.03%, 8.56%), which was contained within the pre-defined equivalence margin of [-15%, 15%]. Numerical differences in some adverse events and immunogenicity were reported between Hadlima and Humira in the clinical studies, but they are not considered to be clinically meaningful as the adverse events were not severe and the differences in immunogenicity were transient.
Overall, based on the totality of evidence derived from the comparative structural, analytical and functional, non-clinical, pharmacokinetic and clinical efficacy and safety data, similarity between Hadlima and Humira has been demonstrated. Furthermore, the scientific rationale provided by the sponsor to support the authorization of Hadlima in other indications held by the reference biologic drug is considered adequate and is in line with Health Canadas biosimilar guidance. Comparability of Hadlima and Hadlima PushTouch was demonstrated in terms of pharmacokinetics and injection site pain scores. Therefore, the benefit risk profiles of Hadlima and Hadlima PushTouch are considered favourable for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis and adult Crohns disease and for the treatment of patients with polyarticular juvenile idiopathic arthritis who are 4 years and older and require a full 40 mg dose.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.