Celltrion Launches Omlyclo in U.S., Targeting Early Lead in Omalizumab Biosimilar Market

Celltrion has introduced Omlyclo, the inaugural omalizumab biosimilar in the United States, aiming to seize an early lead in the burgeoning omalizumab biosimilar market. This strategic move is set to bolster the company's growth prospects in the world's largest pharmaceutical market. Omlyclo, a treatment for conditions like chronic spontaneous urticaria and allergic asthma, was launched on October 5 in the U.S. The drug's introduction comes with a 15% lower wholesale acquisition cost compared to the reference product, offering Celltrion a competitive edge.

The U.S. launch follows Omlyclo's successful performance in Europe, where it has rapidly gained market share in 26 countries, with Spain's market share surpassing 90% and Denmark's set to reach nearly 100%. PBM formulary placement is crucial in the U.S., as it influences reimbursement and patient costs, and Omlyclo is recognized as a preferred drug by major PBMs.

Securing this formulary placement has positioned Omlyclo favorably in the U.S. market. Celltrion is also negotiating with other major PBMs, with some discussions nearing completion. The biosimilar is available in three dosages — 75 mg, 150 mg, and 300 mg — catering to individual patient needs. Moreover, Omlyclo has obtained interchangeability status, allowing pharmacists to substitute it for the reference product under certain circumstances, potentially enhancing patient access.

Despite the challenges ahead, Celltrion plans to leverage its established U.S. direct-sales network and expand its PBM coverage to transform Omlyclo into a key growth product in the American market.