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FDA Approves First Interchangeable High-Concentration, Citrate-Free Biosimilar to Humira

Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to AbbVie’s Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.   In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sal...

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