FDA OKs Biosimilar Adalimumab for Autoimmune Conditions

The FDA has approved Sandoz’s biosimilar adalimumab, adalimumab-adaz (Hyrimoz) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

In a prepared statement, Stefan Hendriks, global head of biopharmaceuticals for Sandoz, wrote, "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.

Read more about the approval at the Center for Biosimilars website.