Alvotech Gains EC Approval for Adalimumab Biosimilar

Alvotech, the Icelandic biosimilars company, has won approval from the European Commission (EC) for the marketing of its adalimumab biosimilar, AVT02, which references Humira. The biosimilar product is cutting edge among approved adalimumab products, as it is high concentration (100 mg) and citrate-free, a formulation that has been capturing market share in the European Union (EU) and United States recently.

The EC approval was officially issued November 15, 2021 and publicized by Alvotech this week. Alvotech may yet face hurdles in commercializing AVT02 in the European Union, where competitive bidding in individual markets, partnership arrangements, and potential opposition from Humira's maker, AbbVie, may cause delays. Alvotech made no mention of a possible EU launch date in its announcement.

An FDA review for possible approval of AVT02 is underway, and Alvotech also must successfully resolve ongoing patent litigation with AbbVie before this product can launch in the United States.

The product received a recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in September. The committee's recommendations are pivotal in EC final decisions about medicinal products.

Adalimumab is used in the treatment of autoimmune and inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, and plaque psoriasis. Adalimumab is a tumor necrosis factor (TNF) inhibitor that in binding to TNF neutralizes its activity and induces apoptosis, or death, of TNF-expressing cells.

"We are thrilled by the EC’s approval of our high concentration biosimilar to Humira," said Róbert Wessman, founder and chairman of Alvotech.

The company has poised itself for rapid expansion of adalimumab biosimilar commercialization in multiple global markets via commercialization deals with multiple companies. Alvotech also has an ustekinumab biosimilar referencing Stelara under development. Clinical studies for the biosimilar candidate, AVT04, were begun in July 2021.

In a recent industry conference, Anil Okay, chief commercial officer for Alvotech, said the company had commercialization deals for its pending biosimilars for upwards of 90 countries.

If launched, AVT02 would become Alvotech’s first commercialized biosimilar. The company was founded in 2013 and has administrative and manufacturing facilities in Europe and under construction in China. The company recently announced a $450 investment from a business consortium and plans to take the company public with a stock offering at an undisclosed future date.

The value of the adalimumab market is sizeable. The product brought in roughly $20 billion in revenues in 2020 for AbbVie. Competitor biosimilars have entered the market in the European Union and in the United States there are 6 approved adalimumab biosimilars scheduled for launch in 2023 and as many as 4 others under development that could launch around that time or later.