FDA approval includes indications for seven diseases, including juvenile idiopathic arthritis for patients 4 years of age and older.
Hyrimoz is a tumor necrosis factor (TNF) inhibitor, a small protein highly expressed in certain autoimmune diseases, including rheumatoid arthritis, and promotes inflammation.
In autoimmune diseases, the immune system attacks and destroys the body’s own tissues. Hyrimoz was designed to target and inhibit TNF, which contributes to disease symptoms.
Biosimilars are biologic products that are approved based on studies that demonstrate that they are highly similar to an already approved biologic product (known as the reference product).
Biosimilars, in this case Hyrimoz, have no clinically meaningful differences in safety and effectiveness from the reference product, in this case, Humira.
“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, Sandoz, said in a press release. “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.”
This approval was granted based on results from a comprehensive array of studies that demonstrated Hyrimoz’s equivalency to Humira in terms of safety, efficacy and quality.
In particular, Sandoz conducted a randomized, double-blind, three-arm, biosimilar study that showed that the pharmacokinetics (how the drug moves through the body) and safety of Hyrimoz was similar to Humira’s.
In fact, the study achieved the primary objective, demonstrating that all major pharmacokinetic parameters were the same between Hyrimoz and Humira.
Additionally, researchers conducted a confirmatory efficacy and safety biosimilarity study (ADACCESS) (NCT02016105), which indicated that Hyrimoz held similar therapeutic benefits in patients with moderate to severe chronic plaque-type psoriasis, as well as a comparable safety profile.
According to Sandoz, this approval follows the global resolution of all lawsuits with AbbVie related to intellectual property concerning Hyrimoz ,which was settled in October.
The newly obtained license allows for patients to be prescribed Hyrimoz in the U.S. starting Sept. 30, 2023.