U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

First Omalizumab Biosimilar Approved

(MedPage Today) -- The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory condition in the U.S., drugmaker Celltrion announced Monday. The anti-immunoglobulin E (IgE) antibody...

U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDARegulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1]The availability of the first omalizumab…

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FDA Approves First Biosimilar of Xolair

Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.

Palo Alto – The first phase of the OUtMATCH study showed last year that the IgE antibody omalizumab can protect children and adolescents with food allergies from severe allergic reactions after accidental exposure. The study, which was presented at a congress of the American Academy of Allergy Asthma & Immunology (AAAAI) and...