Celltrion has received marketing authorization from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). It has been approved for the full range of indications previously approved for Remicade®, namely rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn’s disease, and adult ulcerative colitis.
This news comes as Celltrion launched Remsima® SC in Brazil on 22 May 2023, and has received approval in several other jurisdictions (Europe, Korea and Canada) for treatment of various inflammatory conditions.