Celltrion’s autoimmune disease treatment, Steqeyma (ustekinumab), has captured over 16% of the U.S. market share, signaling rapid prescription growth. The company’s U.S. operations are poised for expansion, bolstered by steady growth of existing products and the rollout of new offerings.
IQVIA, a leading pharmaceutical market research firm, reports that Steqeyma achieved a 16.2% market share in the U.S. this July. This marks a significant 6 percentage point increase in just five months, following its breakthrough into double digits with a 10.2% share in February, roughly a year after its launch.
Steqeyma is a biosimilar version of Janssen’s autoimmune disease treatment, Stelara. Since its U.S. debut, Celltrion has strategically expanded insurance coverage by securing preferred drug status for Steqeyma in major pharmacy benefit managers’ (PBMs) formularies.
PBMs play a crucial role in the U.S. healthcare system, negotiating drug prices and coverage between pharmaceutical companies and insurers. Their influence on patient access to medications makes them a critical checkpoint for biosimilars entering the market.
Another of Celltrion’s autoimmune treatments, Yuflyma (adalimumab), has also gained traction, securing a 9.4% market share in July. Uplima’s coverage expanded late last year when it was added to the public insurance formularies of two of the three largest U.S. PBMs.
Celltrion aims to maximize sales synergy between Steqeyma and Uplima through its U.S. direct sales network, capitalizing on the overlap in their target demographics, which include autoimmune specialists and insurance providers.
Beyond autoimmune treatments, Celltrion is diversifying its U.S. biosimilar portfolio to include oncology products.
The company is doubling down on its direct sales approach, leveraging its U.S. subsidiary to engage directly with local insurers, PBMs, and healthcare professionals. This strategy has accelerated Steqeyma’s market penetration, evidenced by its inclusion in major PBM formularies since launch.
Celltrion’s established products continue to dominate in the U.S. market. The blood cancer treatment Truxima (rituximab) maintained its position as the most prescribed drug in its class for six consecutive months, boasting a 38.6% market share in July.
Similarly, the infliximab biosimilar Inflectra (marketed as Remsima in the U.S.) held a strong position with a 30.7% market share.
Looking ahead, Celltrion plans to introduce Omliclo (omalizumab), a treatment for allergic asthma and chronic spontaneous urticaria, to the U.S. market.
Omliclo received the U.S. Food and Drug Administration (FDA) approval for its 300 mg formulation last year, complementing its existing 75 mg and 150 mg pre-filled syringe options. Notably, it has secured interchangeable biosimilar status in the U.S., allowing pharmacists to substitute it for the original drug, Xolair, without consulting the prescribing physician.
A Celltrion spokesperson stated that with Steqeyma solidifying its market leadership and the entire product line showing strong performance in the U.S., it’s set to capitalize on the direct sales network. It’ll focus on accelerating prescription growth and successfully launching new products like Omlyclo to drive continued revenue growth in the U.S. market.