Health Canada Approves First Biosimilar of Stelara

Alvotech and JAMP Pharma Group have jointly announced that Health Canada has granted marketing authorization to JAMP Pharma for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech. The biosimilar will be available in the market under the brand name JamtekiTM.

JamtekiTM is currently approved in two presentations: a 45mg/0.5mL pre-filled syringe with a passive safety device for subcutaneous injection (PFS-SD) and the 90mg/mL PFS-SD. This marks the second biosimilar to receive marketing authorization under the exclusive commercialization partnership between Alvotech and JAMP Pharma. The partners had previously launched Simlandi®, a biosimilar to Humira® (adalimumab), last year.

In February 2022, JAMP Pharma introduced BioJAMPTM as part of its strategic initiative to establish itself as a leader in the Canadian biosimilars market. BioJAMPTM, along with the JAMP CareTM patient support programs, aims to simplify the transition process to biosimilar medicines for patients and caregivers.

The exclusive partnership between JAMP Pharma and Alvotech for the commercialization of biosimilars in Canada was initially announced in January 2022 and was later expanded in October 2022. In addition to Simlandi® (adalimumab) and JamtekiTM (ustekinumab), the partnership encompasses four biosimilar candidates in clinical development and two biosimilar candidates in pre-clinical development.

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