FDA Approves Biosimilar Adalimumab

The Food and Drug Administration (FDA) has approved another biosimilar adalimumab, marketed as Hyrimoz (adalimumab-adaz), in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. 

The latest treatment is the U.S.’s third biosimilar to Humira (adalimumab), following Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm). 

Hyrimoz is manufactured by Sandoz, a division of Novartis. 

The FDA’s approval comes after a phase 3 randomized, double-blind, controlled, 51-week study that compared the efficacy of Hyrimoz against Humira in adult patients with active, clinically stable, moderate-to-severe plaque psoriasis. Patients were randomly assigned to receive 80 mg of Hyrimoz (n = 231) or Humira (n = 234) at baseline, then 40 mg biweekly from week one. After 17 weeks, patients either switched (n = 126) or continued treatment (n = 253). 

At week 16, 66.8% of Hyrimoz patients and 65% of Humira patients achieved ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) (95% CI -7.46 to 11.15). From weeks 17 to 51, PASI improved overtime and was similar between the switched and continued treatment groups. Researchers observed no safety or immunogenicity differences between the two groups after 16 weeks or from weeks 17 to 51, and no patients experienced hypersensitivity to adalimumab upon switching. 

According to the FDA, the most common adverse reactions (incidence > 10%) were infections, injection site reactions, headache, and rash. 

“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, in a 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.” 

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SourceFDA, Healio, SandozBritish Journal of Dermatology