Celltrion launches Omlyclo, the first omalizumab biosimilar in the U.S

Celltrion has launched Omlyclo, the first omalizumab biosimilar in the United States, targeting chronic spontaneous urticaria and allergic asthma. The drug was released with a wholesale acquisition cost (WAC) approximately 15% lower than the original product and is available in three dosages: 75mg, 150mg, and 300mg.

Upon its launch, Omlyclo was immediately listed as a ‘preferred drug’ on the private insurance formulary of Optum, one of the three largest pharmacy benefit managers (PBMs) in the U.S. Celltrion is currently in the final stages of negotiations with other major PBMs to expand insurance coverage and patient access.

The product has secured FDA approval for all original indications, including asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergies. Additionally, it has obtained interchangeability status, allowing it to be substituted for the original product at the pharmacy level under certain conditions. Celltrion aims to replicate its European success, where Omlyclo has achieved market shares exceeding 90% in Spain and is projected to reach 98% in Denmark.