Celltrion has entered the U.S. market for omalizumab biosimilars with the launch of Omlyclo, aiming to replicate the early market penetration it achieved in Europe and establish the product as a key growth driver in the world’s largest pharmaceutical market.
Celltrion said Tuesday that it launched Omlyclo (omalizumab) in the United States on Oct. 5 local time. The drug is used to treat conditions including chronic spontaneous urticaria and allergic asthma.
Omlyclo is the first omalizumab biosimilar launched in the U.S., giving Celltrion a first-mover advantage as it seeks to secure market share ahead of potential competitors.
The company has also secured an important foothold in the U.S. reimbursement system. Omlyclo was included as a preferred drug on the commercial formularies managed by Optum, one of the country’s major pharmacy benefit managers (PBMs), from the time of its launch.
PBM formulary placement is considered a critical factor in expanding access to prescription medicines in the U.S., as it can influence reimbursement conditions and patients’ out-of-pocket costs. Celltrion is also negotiating with other major PBMs, with some discussions reportedly nearing completion.
Omlyclo is priced at a wholesale acquisition cost approximately 15% below that of the reference product, giving Celltrion an additional lever to compete in the U.S. market.
The product is available in three dosage strengths — 75 mg, 150 mg and 300 mg — allowing physicians to select treatment options according to individual patient needs.
Omlyclo also offers broad regulatory coverage. The U.S. Food and Drug Administration approved the product in March 2025 for all indications held by the reference product in the U.S., including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and IgE-mediated food allergy.
Celltrion has also secured interchangeability status for Omlyclo. Subject to applicable state laws and insurance requirements, the designation allows pharmacists to substitute the biosimilar for the reference product in certain circumstances, potentially improving patient access and supporting wider adoption.
The U.S. launch follows strong performance for Omlyclo in Europe, where Celltrion has leveraged its first-mover position to rapidly expand market share.
Omlyclo is currently available in 26 European countries. In Spain, its market share surpassed 90% as of July, according to IQVIA. In Denmark, Celltrion expects its share to reach approximately 98% by the end of the year following successful participation in national tenders.
Celltrion plans to apply the same market-entry strategy in the U.S. — launching early, securing reimbursement access and then expanding prescriptions through its commercial infrastructure.
The company believes its established direct-sales network in the U.S. will give Omlyclo an additional advantage. Celltrion can leverage its existing sales, distribution and healthcare-provider networks built around its other biosimilar products.
Its existing portfolio has already gained significant traction in the U.S. Truxima, a rituximab biosimilar, held a 39% market share in August and remained the market leader for the sixth consecutive month. Inflectra, based on infliximab, recorded a 31% share and maintained a leading position.
Other Celltrion products are also gaining ground. Steqeyma, a ustekinumab biosimilar, and Yuflyma, an adalimumab biosimilar, recorded market shares of 15% and 12%, respectively.
Industry observers say the key challenge for Omlyclo will be translating its first-mover advantage and early PBM access into actual prescribing volume. In the U.S., formulary coverage, physician adoption and distribution access all play important roles in determining the speed at which a biosimilar can gain market share.
Celltrion plans to expand its PBM coverage while stepping up marketing efforts targeting healthcare providers, insurers and distribution channels. The company also intends to use real-world prescription data and feedback from physicians and patients to refine its U.S. commercial strategy.
“Omlyclo combines the first-mover advantage as the first omalizumab biosimilar in the U.S. with broad indications, interchangeability and three dosage strengths,” said Kim Bon-joong, CEO of Celltrion’s U.S. subsidiary.
“By securing preferred-drug status with a major PBM at launch, we have also established a solid foundation for expanding prescriptions from the outset,” he said. “We will combine the experience gained from our successful first-mover strategy in Europe with our direct-sales capabilities in the U.S. to develop Omlyclo into one of Celltrion’s key growth products in the American market.”
