OMLYCLO Q Code: Q5154

Drug & Product Overview

HCPCS Descriptor Injection, omalizumab-igec (omlyclo), biosimilar, 5 mg

HCPCS Added Date October 1, 2025

Manufacturer Celltrion USA

Route of Administration Subcutaneous

Generic Status Single-Source; Branded

Dosage Form Injection

About OMLYCLO

Omlyclo is a medication aligned to the HCPCS Q Code: Q5154 for billing, pricing, and reimbursement purposes in the United States. It is an Immunology drug administered via the subcutaneous route and manufactured by Celltrion USA.

Manufacturers, reach out to us to add more information.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Package	Manufacturer	HCPCS Units	WAC	AWP
72606-0035-01	75 MG / 0.5 ML Omlyclo Subcutaneous Injection 75 MG/0.5ML - 1 SYRINGE, GLASS in 1 CARTON (72606-035-01) / .5 mL in 1 SYRINGE, GLASS	CELLTRION USA, Inc.	15	$660.35 $44.023 / unit	$792.42 $52.828 / unit
72606-0036-01	150 MG / 1 ML Omlyclo Subcutaneous Injection 150 MG/1ML - 1 SYRINGE, GLASS in 1 CARTON (72606-036-01) / 1 mL in 1 SYRINGE, GLASS	CELLTRION USA, Inc.	30	$1,320.70 $44.023 / unit	$1,584.84 $52.828 / unit
72606-0054-01	300 MG / 2 ML Omlyclo Subcutaneous Injection 300 MG/2ML - 1 SYRINGE, GLASS in 1 CARTON (72606-054-01) / 2 mL in 1 SYRINGE, GLASS	CELLTRION USA, Inc.	60	$2,641.40 $44.023 / unit	$3,169.68 $52.828 / unit

Effective 9/1/26 (WAC & AWP)

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OMLYCLO Pricing & Reimbursement

Q5154 Private Payer Reimbursement

$410.78 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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Historical Graphing and Billing Calculator

NDC Package

HCPCS Units

Markup / Markdown

%

Common:

Estimates only. Payer reimbursement varies by contract, site of care, and sequestration.

Estimated Reimbursement

Omalizumab Biosimilar Information:

OMLYCLO Approval Date: March 7, 2025

Product Name	HCPCS Code	Active Ingredient	BLA Type
Xolair	J2357	Omalizumab	351(a) Originator Product
Omlyclo	Q5154	Omalizumab	351(k) Interchangeable

OMLYCLO CPT Administration Codes

CPT Code	Description
96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular

Not on the CMS JW / JZ list

This product is new and does not yet appear on the CMS list of HCPCS pertaining to single-dose containers. Wastage billing guide →

OMLYCLO Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Asthma Chronic Rhinosinusitis with Nasal Polyps Chronic Spontaneous Urticaria IgE-Mediated Food Allergy

Drug Class

Anti-IgE [EPC]Decreased IgE Activity [PE]IgE-directed Antibody Interactions [MoA]

Frequently Asked Questions

Is there an available Omlyclo billing and coding guide?

Our team has not identified a manufacturer-published source of billing and coding information for OMLYCLO.

Are there any available Omlyclo patient assistance programs?

OMLYCLO patient assistance information can be found through Celltrion USA Inc.. Visit Here →

Where can I find Omlyclo prescribing information?

Omlyclo prescribing information can be found through the link below. Visit Here →

Where can I find Omlyclo side effect information?

Omlyclo side effect information can be found at the link below. Visit Here →

Does billing Omlyclo require wastage modifiers?

CMS does not include OMLYCLO (Q5154) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing Q5154. For more information, visit the link below.

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