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Approval Alert: Alvotech announces US approval of First High Concentration Buffer Free Interchangeable Adalimumab Biosim

Feb 23, 2024

Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®.  SIMLANDI® is the first high concentration adalimumab product to be US approved. It is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and adult ankylosing spondylitis.  AVT02 is already approved in CA, AU, EG, EC and Saudi