Omlyclo was entered the same day as a preferred drug on the commercial formulary of Optum, one of the three largest US pharmacy benefit managers, Celltrion said.
Talks with other large managers are under way, some near completion.
The drug carries a wholesale acquisition cost about 15 percent below Xolair's and comes in 75, 150 and 300 milligram prefilled syringes.
The US Food and Drug Administration cleared it in March 2025 for all four of Xolair's indications and designated it interchangeable, letting pharmacists swap it for the originator where state law and insurance rules allow.
"Omlyclo pairs the advantage of being the first omalizumab biosimilar in the United States with full indication coverage, interchangeability and three dose strengths," said Kim Bon-joong, chief executive of Celltrion USA.
"We will wrap up additional PBM listings quickly and grow it into a major product here."
Omlyclo already sells in 26 European countries and commanded more than 90 percent of the Spanish market as of July, Celltrion said, citing IQVIA data. A national tender win should lift its Danish share to about 98% by year-end, the company said.
Xolair, marketed in the United States by Roche's Genentech unit, posted US sales of 3.08 billion Swiss francs ($3.7 billion) last year, a 32 percent jump driven by its food allergy indication.
AJP Takeaways
- Celltrion on Oct. 5, 2026 launched Omlyclo (omalizumab-igec) in the United States, the first biosimilar to Xolair to reach the US market, and priced it about 15% below the originator's wholesale cost.
- Omlyclo secured a preferred placement on Optum's commercial formulary at launch and holds FDA interchangeability plus approval for all four Xolair indications — asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and IgE-mediated food allergy.
- Xolair generated 3.08 billion Swiss francs in US sales in 2025, up 32 percent, giving Celltrion a multibillion-dollar market to contest as it negotiates listings with the remaining major pharmacy benefit managers.
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