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FDA Approves New Biosimilar


The FDA recently approved adalimumab-adaz (Hyrimoz), a biosimilar of adalimumab (Humira), for the treatment of patients with psoriatic arthritis and plaque psoriasis. Adalimumab-adaz is also indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.


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Approval was based on analytical, preclinical, and clinical data that demonstrated adalimumab-adaz matched the reference biologic in safety, efficacy, and quality. The pharmacokinetics, immunogenicity, and safety of adalimumab-adaz was confirmed in a randomized, double-blind, 3-arm biosimilarity study. In addition, a confirmatory efficacy and safety biosimilarity study showed therapeutic equivalence among patients with moderate to severe chronic plaque psoriasis.


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