The U.S. Food and Drug Administration (FDA) has approved Hyrimoz for the treatment of plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn’s disease in adults, ulcerative colitis, 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
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
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
FDA Approves Sandoz’s Biosimilar Adalimumab, Hyrimoz. The Center for Biosimilars. Available at https://www.centerforbiosimilars.com/news/fda-approves-sandozs-biosimilar-adalimumab-hyrimoz. Accessed 11/2/18.
Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz). Novartis. Available at https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoztm-adalimumab-adaz. Accessed 11/2/18.
Biologics and biosimilars. PhRMA. Available at https://www.phrma.org/advocacy/research-development/biologics-biosimilars. Accessed 11/2/18.
Biosimilars. U.S. Food and Drug Administration. Available at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm. Accessed 11/2/18.