These highlights do not include all the information needed to use OMLYCLO safely and effectively. See full prescribing information for OMLYCLO. OMLYCLO® (omalizumab-igec) injection, for subcutaneous use Initial U.S. Approval: 2025 OMLYCLO® (omalizumab-igec) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of OMLYCLO has been demonstrated for the condition(s) of use (e.g., indication(s) dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to XOLAIR® (omalizumab)

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These highlights do not include all the information needed to use OMLYCLO safely and effectively. See full prescribing information for OMLYCLO. OMLYCLO® (omalizumab-igec) injection, for subcutaneous use Initial U.S. Approval: 2025 OMLYCLO® (omalizumab-igec) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of OMLYCLO has been demonstrated for the condition(s) of use (e.g., indication(s) dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to XOLAIR® (omalizumab)

Medication label

Why this: Advisory · dailymed-prescription

OMLYCLO is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Limitations of Use: OMLYCLO is not indicated for the relief of acute bronchospasm or status asthmaticus. OMLYCLO is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. OMLYCLO is indicated for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. OMLYCLO is to be used in conjunction with food allergen avoidance. Limitations of Use: OMLYCLO is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. OMLYCLO is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: OMLYCLO is not indicated for treatment of other forms of urticaria.

generic_name: omalizumab-igec
product_names: omalizumab-igec
ndc: 72606-035, 72606-035-01, 72606-036, 72606-036-01, 72606-054, 72606-054-01, 72606-054-02
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en