Celltrion’s Stelara biosimilar secures UK approval

Celltrion said its Stelara (ingredient: ustekinumab) biosimilar, Steqeyma, received marketing authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

Steqeyma is set to treat various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

With the approval in the U.K., Celltrion expects to further strengthen its influence in the global ustekinumab market, which was valued at approximately $20.4 billion last year, according to IQVIA, a drug market research firm.

Celltrion plans to leverage its growing product portfolio in the U.K., where it already dominates the infliximab market with its Remsima product line. IQVIA data shows that Remsima achieved an 87 percent market share in the U.K. in the first quarter.

The company stressed that the U.K. has emerged as a leading pro-biosimilar market in Europe, actively supporting the expansion of biosimilar prescriptions through favorable policies. Celltrion aims to accelerate its growth by rapidly expanding its product portfolio in this market.

"The U.K.’s proactive adoption of biosimilar-friendly policies is expected to further expand the influence of our biosimilar products, including Steqeyma,” a Celltrion official said. “We are committed to swiftly bringing high-quality treatments to market to meet patient needs."