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FDA Approves Hyrimoz

FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira

Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps).[1]

The FDA approval of Hyrimoz 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.[2],[3],[4]

Rheumatoid arthritis is among the most common types of arthritis and affects approximately 1.3 million adults in the US.[5] Psoriasis is the most prevalent autoimmune disease in the US, and according to recent studies, as many as 7.5 million Americans-approximately 2.2 percent of the population-have psoriasis.[6]

Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Hyrimoz is the company's third approved biosimilar medicine in the US. Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020.

About Hyrimoz (adalimumab)

Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions-including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis-causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body's own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.[7]

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. As the pioneer and global leader in biosimilars, this settlement helps remove uncertainty regarding when our biosimilar will be available.

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