FDA Approves New Biosimilar

The US Food and Drug Administration has approved adalimumab-adaz (Hyrimoz), a biosimilar to adalimumab (Humira), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 4 years or older, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

The approval comes after a randomized, double-blind, 3-arm parallel biosimilarity study showed that adalimumab-adaz matches adalimumab in terms of safety, efficacy, and quality.

The injection-administered drug is the third FDA-approved biosimilar for adalimumab.

“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 for Sandoz, the manufacturer of Hyrimoz.

“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.”

—Colleen Murphy

Reference:

Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz) [press release]. Holzkirchen, Germany: Novartis; October 31, 2018. https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoztm-adalimumab-adaz. Accessed October 31, 2018.