FDA approves Celltrion's Xolair biosimilar

The Food and Drug Administration has approved Celltrion’s Omlyclo (omalizumab-igec) as a biosimilar designated as interchangeable with Xolair (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated (IgE) food allergy and chronic spontaneous urticaria. 

"We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers," said Hetal Patel, vice president of medical affairs at Celltrion USA. "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."

[Read more: Celltrion receives FDA nod for Prolia, Xgeva biosimilars]

"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," said Thomas Nusbickel, chief commercial officer at Celltrion USA. "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 U.S."