Ustekinumab-stba

- Completed formulary listings with ESI’s public and private insurance plans and Optum’s public insurance plan, securing reimbursement coverage across 35% of the total U.S. insurance market - Vegzelma recorded 10.6% market share in the U.S. bevacizumab sector in May, with rapid growth expected through expanded reimbursement access - High-margin follow-up products including Omlyclo are scheduled to launch in the U.S. in H2, building on the performance of Celltrion’s existing portfolio [July 7, 2026, KST] Celltrion today announced that Vegzelma (bevacizumab), its treatment for metastatic colorectal cancer and breast cancer, has successfully secured formulary listings with two major pharmacy benefit managers (PBMs) in the United States, establishing a foundation for reimbursement coverage. As Vegzelma has already achieved a market share of over 10% through ‘open market’-focused sales activities, this latest achievement is expected to further accelerate its market share expansion. Vegzelma has recently been listed as a preferred drug on the government and commercial insurance formularies of Express Scripts (ESI), one of the top three PBMs in the United States, as well as on the government insurance formulary of Optum, another major PBM. Reimbursement coverage for ESI government plans and Optum has already taken effect from July 1, while reimbursement coverage for ESI commercial plans is scheduled to begin in January next year. In the U.S. pharmaceutical market, the top three PBMs hold significant influence, accounting for approximately 80% of the total insurance market. If a drug is not listed on formularies managed by PBMs, patients are required to purchase the product at its full price without reimbursement, making access to high-cost treatments practically difficult. Through these PBM formulary listings, Vegzelma has secured reimbursement coverage across more than 35% of the U.S. insurance market, establishing a stable foundation for prescription growth. According to IQVIA, Vegzelma recorded approximately 10.6% market share in the U.S. bevacizumab sector as of May, surpassing double-digit market share for the first time since launch and continuing its growth momentum. This result was achieved through Celltrion USA’s focused strategy targeting the U.S. bevacizumab open market and is considered particularly meaningful as Vegzelma delivered strong performance despite entering the market as a latecomer in a highly competitive environment. The open market is a channel supported by the U.S. government that directly connects healthcare institutions and pharmaceutical companies, where a company’s sales capabilities and product competitiveness serve as key factors for market penetration. With these formulary listings, Vegzelma is expected to further accelerate its market share growth by adding new reimbursement access from insurers to the existing growth momentum generated in the open market. Celltrion plans to continue pursuing formulary listing negotiations with other major PBMs to further strengthen Vegzelma’s growth trajectory. In addition to Vegzelma, Celltrion’s other key products, including SteQeyma (ustekinumab) and Yuflyma (adalimumab), are also continuing to perform well in the U.S. market. The two products recorded market shares of 13.3% and 8.1%, respectively, in the U.S. in May, demonstrating stable prescription growth. Also, SteQeyma ranked second in prescription volume among ustekinumab biosimilars despite intense competition following the launch of seven biosimilar products, underscoring the direct sales competitiveness of Celltrion USA. Alongside the performance of its existing products, Celltrion’s U.S. revenue growth is expected to continue as high-margin follow-up products are launched. In the second half of the year, the subcutaneous (SC) formulation of Avtozma (tocilizumab), a treatment for autoimmune diseases, and Omlyclo (omalizumab) are scheduled to be newly launched in the U.S., further strengthening the company’s portfolio. Also, Omlyclo is expected to launch in the U.S. as a first-mover omalizumab biosimilar, positioning it to rapidly capture the market based on its competitive advantage. “Vegzelma has secured a reimbursement foundation in the U.S. by being listed as a preferred drug on the formularies of major PBMs with significant market influence, and we expect this to further accelerate prescription growth,” said an official from Celltrion. “We will continue to pursue formulary listing negotiations with other major PBMs to build on Vegzelma’s achievements, while strengthening the sales performance of Celltrion’s broader portfolio and expanding our market influence in the United States.”