FDA approves Yusimry as Humira biosimilar.
Yusimry is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.
Approval was based on a comprehensive data package that demonstrated the biosimilarity of Yusimry to the reference product, Humira. Data included results from Study CHS-1420-02, a double-blind, randomized, parallel-group, active-control study designed to compare the efficacy and safety (including immunogenicity) of Yusimry versus Humira in 545 randomized subjects with moderate to severe chronic plaque psoriasis, and Study CHS-1420-03, a double blind, randomized, single-dose, parallel-group study to confirm pharmacokinetic similarity by comparing the relative bioavailability between Yusimry and Humira after a single dose of 40 mg SC administered to over 200 healthy subjects.
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