The U.S. Food and Drug Administration (FDA) approved Hyrimoz (adalimumab-adaz, by Sandoz), a biosimilar to AbbVie’s Humira (adalimumab) for the treatment of Crohn’s disease (CD) in adults and ulcerative colitis (UC).
A biosimilar is a therapeutic that has similar active properties to an original product.
“Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a press release.
Hyrimoz is the third approved biosimilar therapy by Sandoz in the U.S. The company plans to launch additional biosimilars for oncology and immunology indications by 2020.
Last month, Sandoz and AbbVie reached a global resolution of intellectual property-related litigation related to Hyrimoz. The license allows U.S. patients to access Hyrimoz as of Sept. 30, 2023.
Adalimumab is an injectable therapeutic that blocks tumor necrosis factor (TNF)-alpha — a pro-inflammatory protein involved in diverse cellular processes, such as cell survival, proliferation, differentiation, and death. TNF-alpha is produced at excessive levels in CD, UC and other autoimmune conditions, leading to inflammation and tissue destruction in the joints, mucosa or skin.
Recently, the European Commission granted marketing authorization to Mylan and Fujifilm Kyowa Kirin Biologics for Hulio, also a biosimilar to Humira. In November 2017, Boehringer Ingelheim’s Cyltezo, another biosimilar to Humira, had also been approved in Europe.
The FDA based its decision on preclinical and clinical data showing that Hyrimoz matches Humira’s safety, efficacy, and quality. The pharmacological profile, immunogenicity — the ability to trigger an immune response — and safety of Hyrimoz were confirmed in a double-blind study.
Then, a Phase 3 confirmatory safety and efficacy trial named ADACCESS (NCT02016105) in 465 patients with moderate to severe chronic plaque-type psoriasis showed that Hyrimoz has therapeutic equivalence to Humira, with a similar safety and immune profile.
Besides the two forms of inflammatory bowel disease (IBD), Hyrimoz was also approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and juvenile idiopathic arthritis in patients age 4 and up.
“With the FDA approval of Hyrimoz, Sandoz is one step closer to offering U.S. patients with autoimmune diseases the same critical access already available in Europe,” Hendriks said.