Regulatory Decision Summary for Jamteki / Jamteki I.V.

The Sponsor is proposing the following changes:

• Addition of a new vial presentation for Jamteki (ustekinumab injection 45 mg/0.5 mL).

• Addition of a new concentration of ustekinumab, i.e., ustekinumab injection 130 mg/26 mL (proposed brand name Jamteki IV).

The Sponsor is also seeking the extension of the currently approved indications, psoriatic arthritis and adult plaque psoriasis, to all Stelara / Stelara intravenous (ustekinumab) indications, psoriatic arthritis and adult/pediatric plaque psoriasis, Crohn’s disease, and ulcerative colitis, based on evidence of biosimilarity.

The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.

Authorization was based on the totality of the evidence presented to establish biosimilarity between Jamteki and the reference product, Stelara (ustekinumab).

The clinical evidence to demonstrate biosimilarity between Jamteki and Stelara were provided and reviewed during the original New Drug Submission (NDS) # 268742 for Jamteki authorized in November 9, 2023. In the present submission, the sponsor provided a justification for extrapolating data and information submitted to support Jamteki as a biosimilar for each indication held by Stelara. The justification was evaluated and considered adequate. Overall, the totality of evidence reviewed in the clinical assessment is supportive of biosimilarity between Jamteki and the reference biologic drug, Stelara for all the indications for which Stelara is authorized, i.e., for the treatment of pediatric plaque psoriasis, Crohn’s disease, and ulcerative colitis.

As such, the benefit-risk profile of Jamteki is consistent with Stelara and is considered favourable.

Establishment of biosimilarity between Jamteki and Stelara is contingent on the pivotal assessment of comparative physiochemical characteristics and functional properties for the presentations proposed.

Overall, the benefit-harm-uncertainty profile was favourable for Jamteki (ustekinumab injection 45 mg/0.5 mL) and Jamteki I.V. (ustekinumab for injection 130 mg/26 mL) for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

An updated Risk Management Plan (RMP) for Jamteki / Jamteki I.V. was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Jamteki / Jamteki I.V. has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Jamteki / Jamteki I.V., please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.