Celltrion announced that its biosimilar Steqeyma, a treatment for autoimmune diseases, has received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The approval allows Steqeyma to treat the same conditions as Janssen’s original drug Stelara, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
This latest approval adds to Steqeyma’s growing global presence, following prior authorizations in South Korea, Canada, and Europe. The global market for Stelara, which Steqeyma replicates, was valued at 26.52 trillion won (approximately $19.76 billion) in 2023, according to data from IQVIA.
Celltrion has been aggressively expanding its biosimilar portfolio in the UK, a market known for its support of cost-effective alternatives to high-priced biologics. The company’s earlier launch of the Remsima biosimilar in the UK has been a success, holding an 87% market share in the first quarter of 2024.
With the approval of Steqeyma, Celltrion continues to build momentum, aiming to expand its product lineup in the UK and capitalize on the favorable policies promoting biosimilar use. The company is positioning itself to capture a larger share of the growing global biosimilar market for autoimmune treatments.