Regulatory Decision Summary for Hadlima / Hadlima PushTouch

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):

adalimumab injection

Therapeutic area:

Biological Response Modifier

Type of submission:

Supplement to a New Drug Submission

Control number:

234258
What was the purpose of this submission?

 

The purpose of this submission was to seek the extension of indications for the biosimilar drug Hadlima (adalimumab) to include pediatric hydradenitis suppurativa (HS) and pediatric uveitis, and to further align the labelling for Hadlima with the reference product Humira.

A Notice of Compliance (NOC) was recommended and issued.

 

Why was the decision issued?

 

As a biosimilar drug to the Canadian reference drug Humira (adalimumab), Hadlima was demonstrated to be biosimilar in its chemistry, non-clinical, and clinical properties when it was authorized in 2018. Since that time, the reference drug, Humira, has added two indications and made alterations to other labelling items such as dosing regimens. Based on its biosimilarity and a scientific justification for expanding the indications for the drug, Hadlima was authorized to add indications for adolescent hydradenitis suppurativa and pediatric uveitis, and to make other changes in labelling in alignment with the reference drug.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.