Biosimilar Hyrimoz Gains FDA Approval

The Food and Drug Administration (FDA) has approved Hyrimoz (adalimumab-adaz; Sandoz), a new biosimilar to Humira (adalimumab; AbbVie).

Hyrimoz, a tumor necrosis factor (TNF)-blocker, is approved for the following indications not protected by orphan exclusivity: rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients ≥4 years, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. 

The FDA’s approval was supported by data from analytical, preclinical, and clinical research showing that Hyrimoz matched the reference product’s safety, efficacy, and quality. Findings from a randomized, double-blind, 3-arm, parallel biosimilarity study confirmed the safety, immunogenicity, and pharmacokinetics of Hyrimoz. The primary endpoint, bioequivalence for all primary pharmacokinetic parameters, was met.

Results from a Phase 3 confirmatory efficacy and safety biosimilarity study (ADACCESS) in patients with moderate to severe chronic plaque psoriasis also demonstrated therapeutic equivalence. After 16 weeks of treatment, 67% of patients in the Hyrimoz group achieved a 75% improvement in the Psoriasis Area Severity Index (PASI) compared with 65% of patients treated with the reference drug.

Hyrimoz will be available as a 40mg/0.8mL injection in prefilled glass syringes in 2-count cartons and prefilled Sensoready Pens in 2- and 6-count cartons. The biosimilar product is not expected to launch until 2023 due to patent disputes with AbbVie.

For more information call (800) 525-8747 or visit Sandoz.com.