Approval of Biosimilar Hyrimoz™ (adalimumab-adaz)

The U.S. Food and Drug Administration (FDA) has approved Hyrimoz for the treatment of psoriatic arthritis (PsA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn’s disease in adults, ulcerative colitis, plaque psoriasis, and juvenile idiopathic arthritis in patients over the age of four. Hyrimoz is a biosimilar for Humira® (adalimumab) manufactured by Sandoz, a division of Novartis Pharmaceuticals.^1,2

What is a biosimilar?

Biosimilars are highly similar to an already approved biological product. Biological products (and biosimilars) are made from living organisms. The sources used to create biological products may be human, animal, bacteria, or yeast.^3,4

Unlike generics, which have the same chemical structure and are exact copies of a reference medicine, biosimilars aren’t exactly like their reference biologics. Biosimilars are generally cheaper than their reference medicine, and they provide another treatment option for patients. Biosimilars must undergo rigorous testing in large clinical trials before they receive approval, and the FDA only approves biosimilars that have the same mechanism of action, route of administration, dosage form, and strength as the reference product.^3,4

How similar are biosimilars to their reference products?

Although not identical, biosimilars need to produce no clinically significant differences in terms of safety and efficacy when utilized by an individual. Biosimilars also need to have the same mechanism of action, route of administration, strength, and dosage form as their reference product, in addition to having no clinically significant differences in terms of purity and potency. When a biosimilar meets all of these requirements and produces the same clinical result as its reference product in any given patient, it can be considered interchangeable, a step up in equivalency.³

Research on Hyrimoz

Hyrimoz was approved based on years of data, including a randomized, double-blind study that included people with moderate to severe chronic plaque psoriasis. Results from the study demonstrated that Hyrimoz was similar in safety and effectiveness to its reference biologic (Humira).²

How Hyrimoz works

The active ingredient in Hyrimoz is adalimumab, a monoclonal antibody that works as a tumor necrosis factor (TNF) inhibitor. TNF is a protein that is involved in the inflammatory response and can be overproduced in inflammatory conditions like RA, PsA, plaque psoriasis, Crohn’s disease, and ulcerative colitis. By blocking TNF, Hyrimoz can help reduce the inflammation and improve the symptoms experienced by patients with these chronic inflammatory conditions.²

Delayed availability of Hyrimoz in U.S.

Although Hyrimoz received the FDA’s approval, it will not be available in the U.S. until 2023. Sandoz, the company that manufactures Hyrimoz, recently settled a patent lawsuit with AbbVie, the manufacturer of Humira. As part of the settlement agreement, Hyrimoz will not be available in the U.S. for any condition until September 30, 2023, although the biosimilar will be available in the European Union.^1,2