Regulatory Decision Summary for Pyzchiva, Pyzchiva I.V.

The purpose of this Supplement to a New Drug Submission (SNDS) (Chemistry and Manufacturing/Labelling) was to request authorization for two new drug presentations for subcutaneous dosing - a pre-filled pen and a single-use vial, and to extend the moderate to severe plaque psoriasis indication to pediatric patients aged 6 to 17 years old based on authorization of the vial presentation and on biosimilarity to the Canadian Reference Biologic Drug (CRBD) Stelara.

The major changes in this submission were the addition of two drug presentations for subcutaneous dosing - a single-use vial (45 mg/1 mL)and a pre-filled pen (PFP; 45 mg/0.5 mL and 90 mg/1.0 mL), as well as the extension of the moderate to severe plaque psoriasis indication to pediatric patients.

The proposed single-use vial (45 mg/1 mL) drug presentation is consistent with that authorized for the Canadian Reference Biologic Drug (CRBD), Stelara, and allows the expansion of the indication to moderate to severe pediatric plaque psoriasis patients, based on biosimilarity with the CRBD Stelara. No concerns were noted from a clinical perspective regarding the proposed new PFP drug product presentation.

Overall, the benefit-risk profile for Pyzchiva remains consistent with the CRBD Stelara, and is therefore considered favourable.

The chemistry and manufacturing information submitted for Pyzchiva has demonstrated that the new presentations of the drug product can be consistently manufactured to meet the approved specifications and that the proposed manufacturing changes result in material comparable to the authorized drug product.

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

The labelling material submitted met all applicable regulations and guidance.

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