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Celltrion is in the final stages of formulary listing negotiations with a major U.S. pharmacy benefit manager (PBM) for its high-margin follow-up biosimilar portfolio, aiming to conclude an additional contract within the fourth quarter of this year. The company plans to continue its earnings growth trajectory in the fourth quarter following record-breaking performance in the third quarter.

Celltrion announced on the 14th that formulary listing negotiations with a major PBM for its high-margin follow-up portfolio in the U.S. market are entering their final stages. In the U.S. pharmaceutical market, formulary inclusion by PBMs significantly influences the expansion of product prescriptions. In particular, securing preferred drug status broadens insurance coverage, improving patient access to medications and facilitating wider adoption in prescribing.

Celltrion has been expanding its presence in the U.S. insurance market by securing consecutive formulary contracts with major PBMs for its follow-up portfolio. Launched in the U.S. in October last year, autoimmune disease treatment Avtozma (ingredient: tocilizumab) was listed as a preferred drug on the commercial formularies of the top three U.S. PBMs, securing insurance reimbursement coverage across more than half of the local health insurance market from early in its launch.

Allergic disease treatment Omlyclo (ingredient: omalizumab), launched in the U.S. earlier this month, was also listed as a preferred drug on the commercial formulary of major PBM Optum. With an additional PBM contract anticipated in the fourth quarter, momentum is expected to accelerate for prescription gains across the company's lucrative follow-up product lines.

Solid market share held by existing flagship products is also driving earnings growth. According to pharmaceutical market research firm IQVIA, as of August this year, blood cancer treatment Truxima (ingredient: rituximab) captured approximately 39% of the U.S. market, defending the top spot in prescriptions ahead of both the original drug and competing biosimilars.

Autoimmune disease therapy Inflectra (ingredient: infliximab, the U.S. brand name for Remsima) also ranked first among biosimilars of the same active ingredient with a 31% market share over the same period. Subsequent portfolio additions Steqeyma (ingredient: ustekinumab) and Yuflyma (ingredient: adalimumab) have also established strong footholds among leading biosimilar prescriptions, holding market shares of 15% and 11%, respectively.

Celltrion's direct sales network and commercial operations established in the U.S. are further supporting the prescription growth of high-margin follow-up products. Celltrion USA is actively leveraging the network of medical institutions and distribution channels built through the sales of its established portfolio to introduce new therapies. By doing so, the company expects to lower initial market entry costs and timelines while enhancing sales efficiency and profitability through its broadened product portfolio.

Riding this growth momentum, Celltrion aims to continue expanding its earnings in the fourth quarter. In the third quarter of this year, the company posted revenue of 1.5 trillion won and an operating profit of 510 billion won, setting a new quarterly record.

A Celltrion official said, "With negotiations for an additional listing with a major PBM in their final stages, discussions are underway with the goal of finalizing a contract within the fourth quarter." The official added, "By combining solid sales of established products and expanded prescriptions of high-margin follow-up lines with our direct local distribution capabilities, we will make every effort to exceed the company's fourth-quarter profit targets."

                                                                                                       Moon Jeong-woo