On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech.  The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL adalimumab, in 40 mg/0.4 mL and 80 mg/0.8 mL presentations).  Health Canada “informed JAMP Pharma that the 40 mg/0.4 mL and 80 mg/0.8 mL presentations of SIMLANDI are not subject to the 24-month statutory stay pursuant to the Patented Medicines (Notice of Compliance) Regulations because AbbVie, the marketer of Humira, elected not to market the equivalent high-concentration versions to Canadian patients.”  Louis Pilon, CEO of JAMP Pharma stated, “We are extremely proud to be the first Canadian company to offer this value-added option at a considerably lower cost than Humira.  SIMLANDI will give Canadians access to a high-concentration, citrate-free form of adalimumab, which is widely used across both Europe and the U.S.”  Robert Wessman, Founder and Chairman of Alvotech, stated, “The combination of Alvotech’s biosimilar development and manufacturing capabilities and JAMP’s market expertise strongly positions the two companies to help Canadian patients.”

We have previously reported on the recommended approval of AVT02 in Europe and a partnership for commercialization of AVT02 in Asia-Pacific markets.