FDA Approves Celltrion's OMLYCLO as First Interchangeable Biosimilar to XOLAIR

Published: 12 Mar 2025

Author: Precedence Research

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The FDA granted its approval for OMLYCLO® (omalizumab-igec) by Celltrion. It is the very first biosimilar drug that can be interchanged for XOLAIR® (omalizumab). The approval provides broader access to omalizumab therapy, increases treatment affordability, and maintains efficacy.

 OMLYCLO® is the first anti-IgE antibody biosimilar approved by the FDA with an interchangeability designation, allowing substitution of OMLYCLO® for XOLAIR® with assured confidence that the risk of decreased effectiveness or increased safety concern would not be an issue. Supporting OMLYCLO®'s approval was strong Phase III clinical trial data.

Clinical Trial Evidence Supporting FDA Approval

The FDA has approved the interchangeability for OMLYCLO®, a biosimilar for chronic spontaneous urticaria (CSU). The decision was predicated upon a Phase III study conducted on 619 adult patients. The patients received either 300 mg or 150 mg of either OMLYCLO® or XOLAIR® every four weeks. The study showed comparable outcomes of two biosimilars concerning safety and therapeutic equivalence. For an interchangeable biosimilar to qualify, the biosimilars must meet additional FDA requirements. Interchangeability will allow pharmacists to switch from the reference drug to the biosimilar without the prescriber's approval. This approval is a step forward in increasing patient access to treatment and creating potential savings for healthcare providers and insurance payers. According to Hetal Patel, VP of Medical Affairs, Celltrion USA, this designation for interchangeability of OMLYCLO® increases confidence in physicians and patients that switching from one product to the other does not reduce effectiveness or increase safety risk whatsoever.

Expanding Access and Reducing Healthcare Costs 

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, heralds the impressive possibilities of having biosimilars like OMLYCLO® to create a solution that can treat patients more affordably and at the same time up the standard of quality in treatment. The product OMLYCLO® will surely be relevant to patients suffering from allergic and respiratory conditions such as moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergies, and chronic spontaneous urticaria (CSU). The FDA has approved the use of the agent for various indications, specifically: moderate to severe persistent asthma in patients aged six years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen; chronic rhinosinusitis with nasal polyps in adults aged 18 years and older who have not responded adequately to a nasal corticosteroid; IgE-mediated food allergy in patients aged one year and older; and chronic spontaneous urticaria in patients aged 12 years and older who continue to have symptoms despite H1 antihistamine treatment.

A Milestone for Biosimilar Development

The first interchangeable biosimilar to XOLAIR® is OMLYCLO®, and it received FDA approval. This is a good indication of the drug being manufactured in response to the high price of biologics. Celltrion, a biosimilar innovator, was the first to obtain interchangeability for OMLYCLO®, thereby confirming its leadership in development, manufacturing, and commercialization. With this FDA approval, a path has been opened for more biosimilar development, thereby ensuring competition and patient access. In May 2024, OMLYCLO® had already received approval from the European Commission, endorsing confidence in its efficacy and safety across the globe. This approval changes the course of biosimilars, offering a high-quality, cost-effective alternative for a biologic product with mass usage.