Omlyclo, the first FDA-approved interchangeable biosimilar to Xolair (omalizumab), is now commercially available in the U.S. Made by Celltrion, it treats the same four allergic and inflammatory conditions as Xolair — and pharmacists can swap it in without a new prescription. The move aims to lower costs and expand access for patients who've faced barriers to biologic treatment.
Celltrion's Omlyclo (omalizumab-igec) — the first and only FDA-approved interchangeable biosimilar to Xolair — has officially hit the U.S. market. Originally approved in March 2025, Omlyclo is cleared to treat four conditions: moderate-to-severe persistent asthma (ages 6+), IgE-mediated food allergy (ages 1+), chronic spontaneous urticaria (ages 12+), and chronic rhinosinusitis with nasal polyps (adults 18+). A higher 300 mg/2 mL dose received FDA approval in December 2025, and all three doses are now commercially available in prefilled syringes.
Because Omlyclo is designated as interchangeable with Xolair, pharmacists can substitute it without requiring a new prescriber order — subject to state pharmacy laws. This is a meaningful distinction that could accelerate uptake at the pharmacy level.
Key Takeaways:
Why it matters: Biologics like Xolair are among the priciest drugs in the U.S. system, and many patients face prior authorizations, step therapy requirements, or high copays that delay or interrupt treatment. Omlyclo's commercial launch introduces real competition into this space — potentially freeing up resources and getting more eligible patients on therapy.
