Celltrion launches Omlyclo in U.S., first omalizumab biosimilar, listed on Optum formulary
Version 2: A further outlet, Chosun Ilbo, has reported the launch, adding that the original product Xolair was jointly developed by Novartis and Roche; no other substantive facts changed.
In short
Celltrion said it launched Omlyclo, its omalizumab biosimilar, in the United States on Oct. 5 local time, the first such biosimilar on that market. The product carries a wholesale price about 15% below the original and is listed as a preferred drug on Optum's commercial formulary, Celltrion said. The company says it is negotiating listings with other large U.S. pharmacy benefit managers.
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Celltrion said it launched Omlyclo, its omalizumab biosimilar, in the United States on Oct. 5 local time, making it the first omalizumab biosimilar to enter that market, according to the company. The wholesale acquisition cost is about 15% below that of the original product, Celltrion said. It is supplied in three strengths: 75 mg, 150 mg and 300 mg. Seoul Economic Daily and Chosun Ilbo identified the original product as Xolair, which Chosun Ilbo said was jointly developed by Novartis and Roche. [ 1 , 2 , 4 , 6 ]
The product was approved by the U.S. Food and Drug Administration in March 2025, the documents say. Asia Economy and Seoul Economic Daily said the approval covers the full set of indications the original holds in the United States — asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and IgE-mediated food allergy. Yonhap listed asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. All three outlets said Omlyclo holds interchangeable status, which allows pharmacies to substitute it for the original where state law and insurance policies permit. [ 1 , 2 , 4 ]
At launch, Celltrion secured a listing as a preferred drug on the commercial formulary of Optum, which Seoul Economic Daily described as one of the three largest pharmacy benefit managers in the United States. Formulary placement is described by the outlets as a key gate for insurance reimbursement and patient access. Celltrion said it is negotiating listings with other large PBMs and that some talks are close to a contract, without naming them. [ 1 , 2 , 4 , 6 ]
The company pointed to its European sales as the basis for the U.S. push. Omlyclo is sold in 26 European countries, and according to Celltrion held more than 90% of the omalizumab market in Spain as of July and is expected to reach about 98% in Denmark by the end of the year on the back of a national tender win. Yonhap reported that sales in Italy have also exceeded the company's initial target. [ 1 , 2 , 4 ]
In the United States, Celltrion plans to use the direct sales force and distribution network built for its existing products. It said Truxima, a blood cancer treatment, held a 39% share in August, which Yonhap reported as first place for six consecutive months, while Inflectra held 31%, Steqeyma 15% and Uplyma 12%, according to Asia Economy and Seoul Economic Daily. Inflectra is the U.S. name for Remsima, Yonhap said. [ 1 , 2 , 4 ]
Kim Bon-joong, CEO of Celltrion's U.S. subsidiary, said Omlyclo combines first-mover advantage as the first omalizumab biosimilar in the United States with full indications, interchangeability and three dosage strengths, and that the company will complete additional PBM listings quickly to make it a major growth product in the United States. A Celltrion official told Yonhap the company will begin marketing to medical staff, insurers and distribution channels, adding that it intends to repeat the fast European market penetration in the United States. [ 1 , 2 , 4 ]
Korea Economic Daily and Newsis also reported the launch, in headlines describing it as the first omalizumab biosimilar and as having secured a large PBM. The article text available from those two outlets concerned unrelated subjects. [ 3 , 5 ]
Why it matters
An early formulary listing gives Celltrion a head start in the U.S. omalizumab market, where pharmacy benefit manager placement largely decides whether a biosimilar is dispensed and reimbursed. Celltrion is pointing to European market-share gains as evidence it can repeat the pattern in the United States. Korean business outlets frame the launch as a test of whether the company's existing U.S. sales network converts a launch into prescriptions.
Key facts
- Celltrion said it launched Omlyclo, an omalizumab biosimilar, in the United States on Oct. 5 local time. [ 1 , 2 , 4 ]
- The product is the first omalizumab biosimilar launched in the U.S. market, according to the company. [ 1 , 2 , 4 , 5 , 6 ]
- Its wholesale acquisition cost is about 15% below the original product, Celltrion said. [ 1 , 2 , 4 ]
- It is supplied in three strengths: 75 mg, 150 mg and 300 mg. [ 1 , 2 , 4 ]
- The FDA approved Omlyclo in March 2025, and the product holds interchangeable status. [ 1 , 2 , 4 ]
- Optum lists Omlyclo as a preferred drug on its commercial formulary, and Celltrion says talks with other large PBMs are under way. [ 1 , 2 , 4 , 6 ]
- Celltrion says Omlyclo is sold in 26 European countries, with more than 90% share in Spain as of July. [ 1 , 4 ]
- Celltrion said Truxima held a 39% U.S. share in August, and reported shares of 31% for Inflectra, 15% for Steqeyma and 12% for Uplyma. [ 1 , 2 , 4 ]
Confirmed by several sources
- Celltrion launched Omlyclo, its omalizumab biosimilar, in the United States. [ 1 , 2 , 3 , 4 , 5 , 6 ]
- The U.S. wholesale price is about 15% below the original product. [ 1 , 2 , 4 ]
- The product comes in 75 mg, 150 mg and 300 mg strengths. [ 1 , 2 , 4 ]
- Omlyclo holds FDA approval granted in March 2025 and interchangeable status. [ 1 , 2 , 4 ]
- Omlyclo was listed as a preferred drug on Optum's commercial formulary at launch. [ 1 , 2 , 4 , 6 ]
- Celltrion is negotiating formulary listings with other large U.S. PBMs. [ 1 , 2 , 4 ]
- Celltrion's Truxima held a 39% U.S. share in August, with Yonhap reporting it as first place for six consecutive months. [ 1 , 2 , 4 ]
Still unclear
- Which other pharmacy benefit managers Omlyclo may be listed with, and when those decisions will come. Documents 1, 2 and 4 say negotiations are under way and that some are close to signing, but no PBM is named and no date is given.
- Early U.S. prescription volumes or sales for Omlyclo. The launch was reported on Oct. 5-6; no uptake figures appear in the documents.
- Whether the FDA-approved indications include IgE-mediated food allergy. Documents 1 and 4 list food allergy among the approved indications; document 2 lists only asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
- Inflectra's exact U.S. market share. Documents 1 and 4 give 31%; document 2 says only that it remains in the leading group.
- What Korea Economic Daily and Newsis reported in detail beyond their headlines. The article text available from those two outlets concerned unrelated stories, so only their headlines could be used.
What local media are saying
Timeline, local time
- Celltrion launches Omlyclo in the United States, in U.S. local time, according to Seoul Economic Daily. [ 4 ]
- Asia Economy reports the launch, the 15% lower wholesale price, the three dosages and the Optum formulary listing. [ 1 ]
- Yonhap reports the launch, citing Celltrion, and says Truxima held 39% in August for six consecutive months at first place. [ 2 ]
- Korea Economic Daily reports the launch in a headline as the first omalizumab biosimilar. [ 3 ]
- Seoul Economic Daily reports the launch date, the 15% lower wholesale price and the PBM negotiations. [ 4 ]
- Newsis reports the launch and that a large PBM had been secured. [ 5 ]
- Chosun Ilbo reports the launch, naming the original product Xolair. [ 6 ]