Alvotech gets a marketing license in the US

The Food and Drug Administration (FDA) of the United States of America has granted the Icelandic company, Alvotech, the authorization to sell and market Simlandi, a biopharmaceutical analog of the primary drug Humira, used in rheumatoid arthritis and inflammatory diseases.

Alvotech announced that Simlandi (adalimumab-ryvk) is the first bio-pharmaceutical analog of Humira, without citrate and in high concentrations, to be licensed by the FDA with exchangeability. The marketing authorization also grants exclusive rights to market the high concentration of the drug in the United States.

Bio-pharmaceutical-similars to Humira in low-dose are already on the market in the United States, but the most commonly prescribed drug is high-dose. Drugstores can supply the analog instead of the primary drug without medical intervention.

One of the most-sold medicines in the world

Teva Pharmaceutical, Alvotech’s US-based partner, is responsible for selling and marketing Simland. Humira was one of the best-selling medicines in the world in 2022, with sales of approximately ISK 1,680 billion in the US.

“A marketing authorization in the US is important for Alvotech. Our goal is to increase access to more cost-effective bio-pharmaceuticals for patients around the world and now the US joins the many states that have granted marketing authorizations for Alvotech bio-pharmaceutical analogs,” commented Róbert Wessman, Chairman and CEO of Alvotech.

“We believe that bio-pharmaceutical analogs are an essential part of reducing healthcare costs, especially in the US where more than 40% of the total cost of medicines is due to bio-pharmaceuticals. The US market is still developing rapidly and a shift may now take place when adalimumab is finally available as a bio-pharmaceutical analog in high concentration with substitutability.”