FDA Approves Sandoz's Biosimilar Adalimumab, Hyrimoz

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).

The drug has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

In a statement, Stefan Hendriks, global head of biopharmaceuticals for Sandoz, said, "Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease. 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."

Sandoz submitted its Biologics License Application (BLA) for the adalimumab biosimilar in January of this year. The BLA included data from the phase 3 ADACCESS study in patients with moderate to severe chronic plaque psoriasis.

Results of the study, which were presented at the American Academy of Dermatology Annual Meeting in March 2017, demonstrated that the biosimilar had similar efficacy to the reference Humira; after 16 weeks of treatment, 67% of patients receiving the biosimilar achieved a 75% improvement in their symptoms (as measured by the Psoriasis Area Severity Index) versus 65% of those treated with the reference product. The biosimilar’s safety profile was also similar to that of the reference.

Despite today’s approval, US patients will have to continue to wait for access to Hyrimoz, as the biosimilar will not enter the US market until 2023. Earlier this month, Sandoz announced a global settlement of patent disputes with AbbVie over the drug. While the settlement allowed Sandoz to launch Hyrimoz in the European Union on October 16, 2018, it forestalled US market entry until September 30, 2023.

Hyrimoz recently launched in the United Kingdom, having received the European Commission’s authorization to market the drug in July 2018 following a positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2018.