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The approval was based on a comprehensive data package demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy, and quality.
The FDA has approved the biosimilar Hyrimoz™ (adalimumab-adaz), announced the manufacturer, Sandoz, a Novartis division, in a press release. The FDA granted approval for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients 4 years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease,” said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. “With the FDA approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe.”
The FDA approval was based on a comprehensive data package comprising analytical, preclinical, and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy, and quality. A randomized, double-blind, three-arm, parallel biosimilarity study confirmed the pharmacokinetics, immunogenicity, and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A confirmatory efficacy and safety biosimilarity study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic.
On October 11, 2018, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie concerning all indications of the proposed Sandoz biosimilar adalimumab for the reference medicine. The license enables patient access in the US to Hyrimoz (or Sandoz adalimumab or Sandoz biosimilar) as of September 30, 2023.
Sandoz receives US FDA approval for biosimilar Hyrimoz™ (adalimumab-adaz) [press release]. Holzkirchen, Germany: Sandoz International GmbH; October 31, 2018.