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). 

#FDAapproves Hyrimoz (adalimumab-adaz), biosimilar to Humira (adalimumab): https://t.co/7nCByZVsbE.
Learn more about #biosimilars here: https://t.co/NDseaneArN. pic.twitter.com/mrr3VsEAHi

— FDA Drug Information (@FDA_Drug_Info) October 31, 2018

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. 

FDA Approves #Hyrimoz (adalimumab-adaz), a Biosimilar to #Humira – https://t.co/RKgRqR0vak

— Drugs.com (@Drugscom) October 31, 2018

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.” 

Risankizumab for Moderate-to-severe Plaque Psoriasis 

A real life comparison of the effectiveness of adalimumab and golimumab in moderate-to-severe ulcerative colitis, supported by Propensity Score analysis. 

The Biosimilar Roundup 

Effectiveness and safety of anti-TNF therapy for inflammatory bowel disease in liver transplant recipients for primary sclerosing cholangitis: A nationwide case series 

Source: FDA, Healio, Sandoz, British Journal of Dermatology