U.S. License Holder:
Genentech
Date of License:
June-20-2003
Last Update:
Dec-15-2024
FDA-Approved Indications
XOLAIR (omalizumab) is an anti-IgE antibody indicated for:
Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids;
Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment;
IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance;
Chronic idiopathic urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Accepted by FDA
CT-P39: Celltrion (submitted March-2024 with request for interchangeability)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Omlyclo® (Celltrion) (December-2024)
Biosimilars Approved In The E.U.
Omlyclo® (Celltrion) (May-2024 E.U.; July-2024 U.K.)
Biosimilars Approved In South Korea
Omlyclo® (Celltrion) (June-2024)
U.S. Patent Litigations
