South Korean biosimilar giant Celltrion announced Wednesday that Steqeyma, the company's biosimilar referencing Stelara, has been approved in the UK, following earlier approvals by Korea, Canada and the European Commission this year.
According to the company, Steqeyma has received approval from the UK's Medicines and Healthcare Products Regulatory Agency for its uses in all indications of reference product Stelara, including psoriatic arthritis, Crohn's disease and ulcerative colitis.
Stelara is Johnson & Johnson's ustekinumab medication, primarily used to treat patients with plaque psoriasis. According to market research firm IQVIA, the global ustekinumab market was valued at approximately $20.4 billion last year.
Celltrion sees the recent approval in the UK as a strategic opportunity to strengthen its presence in the country's biosimilar market, in particular as the UK has been increasingly encouraging the prescription of biosimilar products, recently.
The approval also enhances Celltrion’s autoimmune disease treatment portfolio in the UK, which includes TNF-α inhibitors such as Remsima, Remsima SC -- known as Zymfentra in the US -- and Yuflyma, along with IL inhibitors like Steqeyma.
"The UK has been actively adopting pro-biosimilar policies, which is expected to further enhance the influence of our biosimilar products," a Celltrion official said. "We are committed to supplying high-quality treatments to the market as quickly as possible to meet patient needs."
Celltrion added that it plans to expand its biosimilar portfolio to up to 11 products by 2025 in the global market, in areas including autoimmune diseases, oncology, bone diseases and ophthalmology.
