[E-Daily Reporter Hong Ju-yeon ] Celltrion(068270)Celltrion’s “Vegzelma” (active ingredient: bevacizumab), a treatment for metastatic colorectal cancer and breast cancer currently on the market, is expected to accelerate its market share growth in the U.S.

Celltrion announced on the 7th that Bevzelma has been listed in the formulary of two major U.S. pharmacy benefit managers (PBMs), successfully establishing a foundation for reimbursement. Given that the drug has already secured a market share of over 10% through sales focused primarily on the U.S. open market, this achievement raises expectations for further market expansion.

Begzelma was recently listed as a “preferred drug”—eligible for priority prescribing—in the public and private insurance formularies of “Express Scripts” (hereinafter ESI), one of the top three U.S. PBMs, as well as in the public insurance formulary of “Optum,” another major PBM. Reimbursement has already begun for ESI’s public insurance and Optum as of the 1st of this month, and reimbursement for ESI’s private insurance is scheduled to begin in January of next year.

The three major PBMs in the U.S. pharmaceutical market wield immense influence, accounting for approximately 80% of the total insurance market. If a drug is not listed in the formulary managed by a PBM, patients must purchase the product at full price without reimbursement, making access to high-cost therapies virtually impossible. Through this PBM listing, Begzelma has secured reimbursement coverage of over 35% in the U.S. insurance market, establishing a stable prescription base.

According to IQVIA, a pharmaceutical market research firm, Begzelma recorded a market share of approximately 10.6% in the U.S. as of last May, marking the first time it has surpassed a double-digit market share since its launch, and its growth momentum continues. This result stems from Celltrion’s U.S. subsidiary’s focused efforts to target the local “open market” for bevacizumab and is highly regarded given that it was achieved despite starting as a late entrant and facing unfavorable competitive conditions.

The “open market” is a market that directly connects healthcare institutions and pharmaceutical companies with the support of the U.S. government, where a pharmaceutical company’s sales capabilities and product competitiveness serve as key factors in market penetration. With its recent inclusion in the formulary, Begzelma is expected to further accelerate its market share growth by adding the new driver of insurance reimbursement coverage to its existing growth momentum in the open market. Celltrion plans to further boost Begzelma’s growth by continuing to pursue listing negotiations with other major PBMs.

In addition to Begzelma, other major Celltrion products such as “Stekima” (active ingredient: ustekinumab) and “Uplima” (active ingredient: adalimumab) are also performing well in the U.S. market. These two products recorded market shares of 13.3% and 8.1%, respectively, in the U.S. last May, demonstrating stable prescription trends.

With the strong performance of existing products combined with the launch of high-margin follow-on products, Celltrion’s revenue growth in the U.S. is expected to continue. In the second half of the year, the subcutaneous (SC) formulation of the autoimmune disease treatment “Aptozma” (active ingredient: tocilizumab) and “Omriclo” (active ingredient: omalizumab) are scheduled for new launches in the U.S. market, further strengthening the company’s portfolio. In particular, “Omriclo,” expected to launch in the U.S. as the first-mover biosimilar of omalizumab, is anticipated to rapidly capture market share by leveraging its competitive advantage.

A Celltrion spokesperson stated, “We expect prescription growth for Vegzelma to accelerate significantly now that it has been listed as a preferred drug in major U.S. PBM formularies, securing a reimbursement foundation,” adding, “We will continue negotiations with other major PBMs to secure Vegzelma’s inclusion and build on this success. We will do our utmost to expand our market influence in the U.S. by boosting sales of the Celltrion product portfolio, including Vegzelma.”