Sandoz gets FDA nod for biosimilar Hyrimoz

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Sandoz gets FDA nod for biosimilar Hyrimoz

By Sandra Levy - 11/01/2018
Sandoz has received the Food and Drug Administration’s blessing for its Hyrimoz (adalimumab-adaz) — a biosimilar of Humira. The drug is indicated to treat rheumatoid arthritis , juvenile idiopathic arthritis in patients four years old and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis

"Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease," Sandoz global head of biopharmaceuticals Stefan Hendriks said in a statement. "With the FDA approval of Hyrimoz, Sandoz is one step closer to offering U.S. patients with autoimmune diseases the same critical access already available in Europe."

Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor, a protein that is overproduced in certain autoimmune conditions, including rheumatoid arthritis, plaque psoriasis, Crohn's disease, 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 Oct. 11, Sandoz announced a global resolution of all intellectual property-related litigation with AbbVie concerning all indications of the proposed Sandoz biosimilar adalimumab, according to the company.

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