When chronic hives won’t quit, a biologic injection can finally bring some relief. Now there’s a new version of one of those medications. As reported by Dermatology Times, Celltrion USA announced that Omlyclo (omalizumab-igec), the first FDA-approved interchangeable biosimilar to Xolair, is now commercially available in the United States.
A biosimilar is a biologic medication that’s highly similar to an existing one, with no clinically meaningful differences. The “interchangeable” label means a pharmacist may be able to substitute it for the original without checking with your prescriber first, depending on state pharmacy laws. It doesn’t mean the biosimilar works better or is safer than Xolair, though.
Who is Omlyclo for?
Omlyclo is approved for chronic spontaneous urticaria (CSU), meaning hives that show up without an obvious trigger. Adults and adolescents 12 and older can use it if they still have symptoms despite taking antihistamines. It isn’t approved for other forms of hives, though it is also approved for certain patients with asthma, chronic rhinosinusitis with nasal polyps and IgE-mediated food allergy. For CSU, it’s given as an injection under the skin, either 150 or 300 milligrams every four weeks. Unlike its other uses, dosing for CSU doesn’t depend on body weight or IgE levels.
Omlyclo carries a boxed warning for anaphylaxis, a severe allergic reaction that can happen after the first dose or more than a year into treatment. Because of that, treatment should begin in a health care setting equipped to manage it. Celltrion says the launch is meant to improve access and affordability, but the company hasn’t shared a price or estimated patient savings. It’s worth asking your pharmacist and insurer what coverage looks like.
For people whose hives have been hard to control, a second version of the same medication could mean more flexibility, and possibly lower costs, down the road. If you’re curious whether it’s right for you, your dermatologist or allergist can help you weigh it.
