Celltrion Launches First Omalizumab Biosimilar in the U.S.

Celltrion has officially launched its first Omalizumab biosimilar, named OMLYCLO, in the United States. This marks a significant milestone as it is the first biosimilar of Omalizumab to enter the U.S. market. OMLYCLO is designed to treat chronic spontaneous urticaria and allergic asthma, providing a more affordable option for patients.

The launch of OMLYCLO is particularly noteworthy as it has been added as a preferred option in the formulary of Optum, one of the major pharmacy benefit managers (PBMs) in the U.S. This strategic move is expected to enhance Celltrion's market reach and accessibility for patients requiring this treatment.

OMLYCLO is priced approximately 15% lower than the original drug, XOLAIR, which is jointly developed by Novartis and Roche. The U.S. Food and Drug Administration (FDA) granted approval for OMLYCLO in March of last year, allowing its use for all conditions treated by the original drug, including asthma and chronic rhinosinusitis with nasal polyps.

In addition to its launch in the U.S., Celltrion has successfully marketed OMLYCLO in 26 European countries, achieving significant market shares in various regions. The company plans to leverage its existing sales networks and is currently negotiating with other PBMs to further expand its reach in the U.S. market.

Kim Bon-jung, CEO of Celltrion's U.S. subsidiary, emphasized the importance of this launch, stating, "As the first Omalizumab biosimilar in the United States, OMLYCLO can be used across all indicated conditions and offers interchangeability and three dosage strengths."