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First Biosimilar Approval Alert: Health Canada Approves Alvotech’s AVT04 commercialised by JAMP as Jamteki™, the First Stelara® (ustekinumab) Biosimilar in Canada

Nov 14, 2023

Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the first approved biosimilar to Stelara® (ustekinumab) in Canada.  AVT04 was developed by Alvotech and will be marketed under the name Jamteki® by JAMP in Canada.  The approved presentations are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

This is the first approved ustekinumab biosimilar in Canda, and the second biosimilar to receive marketing authorisation in Canada under the exclusive commercialization partnership between Alvotech and JAMP Pharma (following Simlandi®, biosimilar to Abbvie’s Humira® (adalimumab)).  The companies announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, which was expanded to seven biosimilars in October 2022.