Alvotech to manufacture Humira biosimilar for Quallent

The monoclonal antibody Simlandi was approved as the first interchangeable, high-concentration, and citrate-free biosimilar version of AbbVie’s blockbuster in February 2024.

Under a longstanding collaboration, Alvotech is responsible for the development and production of the product and Teva oversees commercialization of the drug in the US. However, the deal announced this week will see the biosimilar be distributed under Quallent’s private label.

Iceland-based drugmaker Alvotech said the deal aligns with its US commercialization agreement with Teva.

“Being able to obtain interchangeable exclusivity for the high-concentration formulation which dominates the adalimumab market, has generated significant payor interest for this unique product in the US market,” said Robert Wessman, CEO of Alvotech.

“With our commercial partners for the US we aim to increase healthcare access and ensure that affordable high-quality biologics are available to patients in need.”

AbbVie’s blockbuster drug Humira lost its patent protection last year. As a result, the industry has witnessed a slew of adalimumab biosimilars enter the market. Simlandi’s approval had been delayed due to manufacturing issues at Alvotech’s plant in Reykjavik, Iceland

“We are pleased to be working with Alvotech to bring adalimumab to more patients. Our intent is to offer a copay assistance program, which will provide eligible patients access,” said John Caufield, president of Quallent.

Alvotech and Teva said they expect to launch the biosimilar to patients in the US “imminently.”