Celltrion, Inc. announced that the U.S. FDA has approved a new 300mg version of OMLYCLO® (omalizumab-igec). This is the first and only biosimilar approved to be interchangeable with XOLAIR®. It comes as a single-dose prefilled syringe for subcutaneous injection. In the U.S., the product will be sold and distributed exclusively by Celltrion USA, Inc.
Earlier in March 2025, the FDA approved OMLYCLO in other strengths (75mg and 150mg) for treating conditions like moderate to severe asthma, chronic rhinosinusitis, food allergies, and hives.
OMLYCLO is the first FDA-approved biosimilar to XOLAIR®, and it’s considered therapeutically similar to the original drug, meaning it works the same way for all approved uses. OMLYCLO was approved by the FDA in March 2025 and by the European Commission in May 2024.
This approval marks a significant milestone for Celltrion, as it provides a more affordable option than XOLAIR® for patients. By providing a biosimilar version of an established treatment, Celltrion aims to increase access to important therapies for patients with conditions like asthma and chronic rhinosinusitis.
Executive Statement
According to Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, the approval of the additional 300 mg presentation of OMLYCO underscores their dedication to patients in the U.S., by broadening treatment choices and expanding flexibility, addressing the diverse needs of patients with allergic and inflammatory conditions. The new dosing option of OMLYCLO can help reduce the number of required injections as well as ease the overall treatment burden and discomfort for patients with these diseases.
According to Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, they are proud of the expansion of OMLYCLO's dosing options, marking another significant milestone in their commitment to increasing access to biologic treatments in the U.S. They remain steadfast in their efforts to support physicians with flexible, high-quality treatment options as well as ensure that more patients can benefit from best-in-class care.