Datapoint: FDA Approves Latest Humira Biosimilar

Following months of delays due to manufacturing woes, the FDA last week approved a new Humira biosimilar —Alvotech and Teva’s Simlandi (adalimumab-ryvk). The drug will be the first citrate-free, high-concentration interchangeable Humira biosimilar, which could give it a distinct edge in the U.S. market. Despite the availability of several Humira copies, the branded version continues to dominate. 98% of all insured lives have covered or better access to Humira under the pharmacy benefit, with 54% having preferred access (though this is largely with utilization management restrictions applied). Humira brought AbbVie $14.4 billion in global sales in 2023, which is expected to drop to $9.3 billion in 2024 and $7.3 billion in 2025, according to Evaluate Pharma.

From Evaluate Pharma and MMIT Analytics, as of 2/28/24

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AIS Health Staff

AIS Health Staff

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