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FDA Approves Hyrimoz, Third Humira Biosimilar
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The FDA has approved the third biosimilar to adalimumab, adalimumab-adaz, for all eligible indications of the biologic product, according to a company press release.
Hyrimoz (adalimumab-adaz, Sandoz), a biosimilar to Humira (adalimumab, AbbVie), is a TNF-inhibitor intended to treat patients with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
With this approval, Hyrimoz has become the third biosimilar to Humira to launch in the United States, following Amjevita (adalimumab-atto, Amgen) in 2016 and Cyltezo (adalimumab-adbm, Boehringer Ingelheim) in 2017.
“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a press release. “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.”
The FDA based its approval on a comprehensive data package including analytical, preclinical and clinical research comparing the safety, efficacy and quality of Hyrimoz against the reference product.
Additionally, the FDA considered the results of the ADACCESS trial, a phase 3 randomized, double-blind, controlled, 51-week study for patients with clinically stable but active moderate to severe chronic plaque psoriasis. Study results demonstrated therapeutic equivalence in the sensitive indication of these patients, with a comparable safety and immunogenicity profile to the reference biologic.