Celltrion wins New Zealand approval for autoimmune disease biosimilar
Celltrion's Plant 1 in Incheon / Courtesy of Celltrion
Korean biopharmaceutical company Celltrion said Wednesday its biosimilar for autoimmune diseases has received regulatory approval for sale in New Zealand.
The New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) has approved Steqeyma, Celltrion's biosimilar referencing Stelara, for the treatment of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, the company said in a press release.
Both the Steqeyma injection and Steqeyma prefilled syringe (PFS) formulations have been approved, it added.
Steqeyma is the first Stelara biosimilar to receive approval in New Zealand, according to the company.
"With this latest approval, Celltrion has secured a 'first-mover' position in New Zealand, one of the key markets in the Oceania region, giving the company an advantage in initial sales," a company official said.
The global market for Stelara was valued at 30.33 trillion won ($21.7 billion) last year, the company said, citing data from market research firm IQVIA.
With the latest approval, Celltrion's global biosimilar portfolio now includes 11 approved products. The company said it aims to commercialize 22 biosimilars by 2030, when the global biosimilar market is projected to reach 261 trillion won, up from 138 trillion won this year.