Wellington: South Korean biopharmaceutical company Celltrion Inc. announced that its biosimilar for autoimmune diseases has received regulatory approval for sale in New Zealand.
According to Yonhap News Agency, 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 approval includes both the Steqeyma injection and Steqeyma prefilled syringe (PFS) formulations.
Steqeyma is the first Stelara biosimilar to receive approval in New Zealand. A company official noted that this approval positions Celltrion as a 'first-mover' in New Zealand, which is considered a key market in the Oceania region, providing the company with an advantage in initial sales.
The global market for Stelara was valued at 30.33 trillion won (US$21.7 billion) last year, as per data from market research firm IQVIA. With this approval, Celltrion's global biosimilar portfolio now includes 11 approved products. The company aims to commercialize 22 biosimilars by 2030, with the global biosimilar market projected to reach 261 trillion won, up from 138 trillion won this year.