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FDA Approves New Biosimilar

October 31, 2018

The FDA has approved Hyrimoz (adalimumab-adaz; Novartis), a biosimilar of Humira (adalimumab; AbbVie), 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. 

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.

Melissa Weiss

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