REYKJAVIK, Iceland & BOUCHERVILLE, Quebec– Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical company headquartered in the Montreal area, announced today that Health Canada has granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab), developed by Alvotech. The biosimilar medicine, AVT02 (100 mg/mL adalimumab, in 40 mg/0.4 mL and 80 mg/0.8 mL presentations), will be marketed as SIMLANDI in Canada through an exclusive commercialization agreement with JAMP Pharma.
Health Canada also 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 Corporation, the marketer of Humira, elected to not market the equivalent high-concentration versions to Canadian patients. JAMP has accordingly been issued notices of compliance for these presentations of SIMLANDI and can launch them in Canada.
“We are extremely proud to be the first Canadian company to offer this value-added option at a considerably lower cost than Humira,” said Louis Pilon, CEO of JAMP Pharma Group. “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.”
“We will also offer a unique 80 mg/0.8 mL dose to Canadian patients that will reduce the number of starting injections by 50% for the patients that require it,” said Bruno Mäder, President & Chief Operating Officer of JAMP Pharma Group.
“The combination of Alvotech’s biosimilar development and manufacturing capabilities and JAMP’s market expertise strongly positions the two companies to help Canadian patients,” said Róbert Wessman, Founder and Chairman of Alvotech.
Mark Levick, CEO of Alvotech, added, “We are delighted by the approval from Health Canada, which highlights Alvotech’s global approach to biosimilars, and look forward to continued collaboration with JAMP.”
SIMLANDI is a high-concentration, citrate-free biosimilar to Humira, which is used to treat a range of certain inflammatory conditions. Adalimumab inhibits tumor necrosis factor, which is a protein in the body that can cause inflammation. Humira recorded global sales of about USD $20 billion in 2020, making it the highest grossing medicine in the world, and the highest selling medication in Canada with over USD $700 million in sales, according to IQVIA.
On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO.”
In January 2020, JAMP Pharma Group signed an exclusive agreement with Alvotech to collaborate on a broad portfolio of biosimilars. The strategic partnership with JAMP extends Alvotech’s fully integrated value chain from cell line development to commercial manufacturing. JAMP Pharma Group’s existing commercial infrastructure and expertise will allow Canadian patients to benefit from safe and effective biosimilars as well as the JAMP Care™ patient support program, while providing significant cost savings to the healthcare system.
