Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR®? (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc. In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose precutaneous injection for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous ugaria (CSU).
OMLYCLO 75 mg/0.5mL, 150 mg/mL and 300 mg/2mL solutions in a single- dose prefilled syringe for sub cutaneous injection for the treatment ofmoderate to severe persistent asthma, chronicrhinosinusitis with nasal polyPS (CRSwNP), immunoglobulin E (IGE)-mediated food allergy,and chronic spontaneous ugE)-mediated food allergy. OMLYCLO was approved by the U.S. Food & Drug Administration (FDA) and the European Commission (EC) in March 2025 and May 2024, respectively. OMLYCLO (anomalizumab-igec) injection, is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age 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 with inadequate response to nasal corticosteroids, as add-on maintenance treatment; IgE-mediated food allergy in adult and pediatric patients aged 1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods.
Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, endocrinology and ophthalmology include:INFLECTRA®? (infliximab-dyyb), TRUXIMA®?
(rituximab-dyyb, TRUXIMA®?, (rituximab--d) (rituximab-yb), TRuximab-yb). OMLYCLO®? (RX) is the first U.S. Food and drug Administration (FDA-approved biosimilar products in Immunology, hematology,endocrinology and ophthalmology includes: INFLECTRA®?®?
(infilimab-dyb), TRUXimab-dyyb"), TRUXIMA®?®? (rituximib--d.
