Research & Development
Health Canada Approves Simlandi, a High-Concentration Biosimilar to Humira
11 January 2022 - - Health Canada has granted marketing authorization to Canadian owned pharmaceutical company JAMP Pharma Group for a high-concentration biosimilar to Humira (adalimumab), developed by Iceland-based biopharmaceutical company Alvotech Holdings S.A, the companies said.

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 Corp., 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.

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 20bn in 2020, making it the highest grossing medicine in the world, and the highest selling medication in Canada with over USD 700m 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.

The JAMP Pharma Group is a Canadian owned and based company headquartered in the Montreal area. It was founded in British Columbia more than 30 years ago and is present in all segments of the pharmaceutical market.

The JAMP Pharma Group has a portfolio of almost 300 pharmaceutical products as well as more than 160 over-the-counter medicines, vitamins, and supplements in its Wampole and Laboratoire Suisse divisions.

It also ranks amongst the country's top companies in terms of annual prescription volume according to IQVIA1.

The JAMP Pharma Group also provides a comprehensive patient support program called JAMP Care for all its specialty and biologic products.

Alvotech is a biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide.

Alvotech's current pipeline contains seven biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, and cancer.

AVT02 is a monoclonal antibody and a biosimilar to Humira (adalimumab). AVT02 is not approved outside of the EU and Canada. AVT02 dossiers are under review in multiple countries; in the US the BLA is in deferred status, pending FDA inspections.

JAMP Pharma has exclusive commercialization rights to AVT02 in Canada under trade name Simlandi.