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Approval alert: MEDSAFE approves Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab)

Jun 1, 2023

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 (EuropeKorea and Canada) for treatment of various inflammatory conditions.