Sandoz, a division of Novartis, has secured approval from the US Food and Drug Administration (FDA) for Hyrimoz (adalimumab-adaz), its biosimilar of AbbVie’s Humira (adalimumab) for use in all indications as the reference medicine.
The approval paves way for the use of Hyrimoz in the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps).
Adalimumab, which is the active ingredient in Hyrimoz, inhibits tumor necrosis factor (TNF), a protein that is produced in excess in some autoimmune conditions in various autoimmune conditions such as rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis-causing inflammation and tissue damage in joints, mucosa or skin.
Sandoz biopharmaceuticals global head Stefan Hendriks said: “Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease.
“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.”
The FDA approval was given on the basis of analytical, preclinical and clinical research data which proved the biosimilar equivalence of the Sandoz drug to the reference medicine in terms of safety, efficacy and quality.
The biosimilar’s pharmacokinetics, immunogenicity and safety were established by a randomized, double-blind, three-arm, parallel biosimilarity study. The trial met the primary endpoint, showing bioequivalence for all the main pharmacokinetic parameters.
Further, a confirmatory efficacy and safety biosimilarity study, dubbed as ADACCESS, proved therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with an identical safety and immunogenicity profile to the reference drug.
The FDA approval for Hyrimoz follows the drug’s European Commission’s granting of marketing authorization in June 2018 for all indications approved for its reference biologic.
Hyrimoz is the third approved biosimilar of Novartis to be approved by the FDA. The Swiss drug maker expects to launch additional biosimilars for oncology and immunology indications across major regions in the world by 2020.