The Food and Drug Administration (FDA) of the United States has granted Icelandic company Alvotech the approval to sell and market Simlandi, a biopharmaceutical analog of Humira, primarily used in treating rheumatoid arthritis and inflammatory diseases. Simlandi (adalimumab-ryyk) is the first Humira analog licensed by the FDA with exchangeability and lacks citrate. It also comes in high concentrations.
With this FDA authorization, Alvotech secures exclusive rights to market the high concentration of Simlandi in the United States. Although there are already biopharmaceutical analogs to Humira spanning low doses in the country’s market, the most frequently prescribed dosage remains high. This authorization allows drugstores to carry and supply the analog as a substitute for Humira, without requiring a medical intervention.
Humira was one of the top-selling drugs globally in 2022, amassing approximately ISK 1680 billion in sales within the U.S market. Alvotech’s U.S partner, Teva Pharmaceutical, will take charge in selling and marketing Simlandi.
The marketing authorization holds significant value for Alvotech. According to Róbert Wessman, Chairman and CEO of Alvotech, it aligns with their goal to enhance access to cost-effective biopharmaceuticals for patients globally. With this authorization, the U.S joins the growing list of states granting marketing authorizations for Alvotech biopharmaceutical analogs.
Wessman views biopharmaceutical analogs as crucial to reducing healthcare costs, especially in the U.S, where biopharmaceuticals contribute to over 40% of the total cost of medicines. Given the fast-paced development of the U.S market, a shift may occur as adalimumab is now available as an analog in high concentration with substitutability.
