Celltrion has received the US Food and Drug Administration (FDA) approval for Omlyclo (omalizumab-igec) as the first interchangeable biosimilar referencing Xolair (omalizumab).
Xolair is a monoclonal antibody designed to target and bind to Immunoglobulin E (IgE), a type of antibody involved in allergic reactions.
It is jointly developed and marketed by Roche’s subsidiary Genentech, and Novartis.
Omlyclo is approved for all indications of Xolair, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, Immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.
Celltrion is offering Omlyclo in 75mg/0.5 mL and 150mg/mL solutions in single-dose prefilled syringes.
Celltrion USA Medical Affairs vice president Hetal Patel said: “We are proud to achieve the approval of the first biosimilar to omalizumab in the US, which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers.
“The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product.”
The FDA approval of Omlyclo as an interchangeable biosimilar follows the European Commission’s (EU) authorisation in May 2024.
Also, the approval was supported by positive results from a Phase 3 study comparing Omlyclo or Xolair, in 619 adults with chronic spontaneous urticaria.
In the Phase 3 clinical study, Omlyclo showed comparable efficacy and safety profiles with the reference product, Xolair, at 40 weeks.
The US FDA grants the interchangeable biosimilar designation, indicating that the drug meets additional legal requirement, for use as a substitute for the original product.
Celltrion USA chief commercial officer Thomas Nusbickel said: “The approval of OMLYCLO could have a meaningful impact for the medical community and patients, offering a high quality and affordable treatment option, while reducing the burden of healthcare costs.
“With our integrated development, manufacturing, and commercialization platform, Celltrion remains committed to alleviating treatment costs and delivering life-changing medicines to support patients with allergic conditions in the US.”
Last month, Celltrion received the European Commission (EC) marketing authorisation for Avtozma, a biosimilar to Roche’s arthritis drug RoActemra (tocilizumab).
