Sandoz Gets FDA Approval for Humira Biosimilar

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The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

On Oct. 31, 2018, Sandoz, a Novartis division, announced that it received FDA approval for its biosimilar, Hyrimoz (adalimumab-adaz), which references AbbVie’s blockbuster Humira (adalimumab). Humira is AbbVie’s top-selling product with $18.4 billion in 2017 sales.  

FDA granted Hyrimoz approval to treat 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, in a company press release. "With [FDA] approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe."

Hyrimoz is Sandoz's third approved biosimilar medicine in the United States. Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020.


On Oct. 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. Hyrimoz is a trademark of Novartis.

Source: Novartis