TRUXIMA and INFLECTRA maintain strong positions as Celltrion prepares to expand its U.S. portfolio
Celltrion is gaining traction across both new and established biosimilars in the United States, with its newer products increasingly benefiting from the direct-sales network the company has built in the world’s largest pharmaceutical market.
According to pharmaceutical market research firm IQVIA, Celltrion’s ustekinumab biosimilar STEQEYMA captured a 16.2% share of the U.S. market in July.
STEQEYMA reached a double-digit market share of 10.2% in February, roughly a year after its launch, and added another 6 percentage points over the following five months. The pace is notable in the U.S. ustekinumab market, which Celltrion estimates at around 20 trillion won ($14 billion).
The company attributed the growth in part to expanded insurance coverage. Since its initial launch, STEQEYMA has secured preferred status on commercial and public insurance formularies managed by major U.S. pharmacy benefit managers, or PBMs, including the country’s three largest players.
Celltrion has also been expanding its relationships with specialists, insurers and other healthcare stakeholders while operating its own distribution and sales infrastructure in the U.S.
YUFLYMA reaches 9.4% as autoimmune portfolio expands
YUFLYMA, Celltrion’s adalimumab biosimilar, recorded a 9.4% U.S. market share in July, extending its prescription growth.
The product was added to public insurance formularies of two of the three largest U.S. PBMs late last year, giving it broader access to a key segment of the market.
Celltrion sees room for additional synergies between YUFLYMA and STEQEYMA because both target autoimmune diseases. The overlap allows its U.S. sales organization to leverage relationships with many of the same specialists, insurers and other stakeholders rather than building separate commercial networks for each product.
Its established biosimilars, meanwhile, continue to provide a strong base.
TRUXIMA, a rituximab biosimilar used to treat blood cancers and other diseases, held a 38.6% share in July and ranked first in prescriptions for the sixth consecutive month. In August, the U.S. Food and Drug Administration granted TRUXIMA interchangeability designation, making it the first rituximab biosimilar to receive the status.
INFLECTRA, the U.S. brand name for Celltrion’s infliximab biosimilar, also maintained a leading position among biosimilars with a 30.7% market share.
Direct-sales platform becomes a base for broader U.S. portfolio
The latest prescription figures point to a broader shift in Celltrion’s U.S. business. Its direct-sales infrastructure, initially built around established products such as INFLECTRA and TRUXIMA, is increasingly serving as a commercial platform for newer biosimilars.
That could become more important as Celltrion expands its U.S. lineup. The company plans to launch additional higher-margin products, including OMlyclo, its omalizumab biosimilar for conditions including chronic spontaneous urticaria.
With more products using the same sales, distribution and payer networks, Celltrion is seeking to improve commercial efficiency while expanding its presence across multiple therapeutic areas.
“Both our new and established products, including STEQEYMA, which has secured a leading market position, continue to deliver meaningful results and expand their presence in the U.S.,” a Celltrion official said.
The official added that the company plans to accelerate prescription growth by maximizing the effectiveness of its U.S. direct-sales network and successfully launching follow-on products such as OMlyclo.

