Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz)

  • Biosimilar HyrimozTM (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity **
  • Biosimilars are critical to sustaining US healthcare system, providing broader access to vital treatments for prevalent chronic conditions such as psoriasis and rheumatoid arthritis, which affect over eight million Americans combined
  • Hyrimoz is third FDA-approved Sandoz biosimilar in US

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, HyrimozTM (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).

"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 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. , ,

Rheumatoid arthritis is among the most common types of arthritis and affects approximately 1.3 million adults in the US. 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.

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 HyrimozTM (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.

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.

Hyrimoz is a trademark of Novartis AG.

Please see full Prescribing Information for HyrimozTM here.


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