FDA Approves New Biosimilar

10/31/2018
PsA

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.
___________________________________________________________
RELATED CONTENT

Does Psoriasis Increase the Risk of Sexual Dysfunction?
Should Patients With Skin Psoriasis Receive Routine MRI Screening?
___________________________________________________________
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.