Biosimilar, Hyrimoz, Approved by FDA for Host of Chronic Conditions

The US Food and Drug Administration (FDA) has approved Sandoz’s biosimilar, Hyrimoz (adalimumab-adaz), for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

A comprehensive data package composed of data from analytical, preclinical, and clinical research that demonstrated adalimumab-adaz matches the reference biologic regarding safety, efficacy and quality served as the basis for the approval.

The pharmacokinetics, immunogenicity, and safety of adalimumab-adaz were confirmed in a randomized, double-blind, three-arm, parallel biosimilarity study. A demonstration of bioequivalence for all primary pharmacokinetic parameters served as the study’s primary endpoint, which was met.

In the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, therapeutic equivalence was demonstrated by a confirmatory efficacy and safety biosimilarity study (ADACCESS), with a similar safety and immunogenicity profile to the reference biologic.

"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, Sandoz, in a recent statement. "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."

Injection site reactions (erythema and/or itching, hemorrhage, pain or swelling) included the most common adverse reactions noted in clinical trials.

Adalimumab-adaz includes the active ingredient, adalimumab, which is an inhibitor of the over-produced protein tumor necrosis factor (TNF) in certain autoimmune conditions, such as rheumatoid arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis-causing inflammation and tissue destruction in joints, mucosa or skin. By targeting and blocking the protein that contributes to disease symptoms, adalimumab-adaz helps treat the indicated autoimmune diseases that can damage the body's own tissues.