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Celltrion Secures First Approval of Infliximab IV Liquid Formulation

Nov 18, 2025

On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the powder formulation, including rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.  According to Celltrion, the product is the world’s first liquid formulation of IV infliximab.

Celltrion’s Remsima®, biosimilar to Janssen’s Remicade® (infliximab), has been approved in Europe since 2013 and was launched in major European countries in early 2015.  Subcutaneous infliximab (Remsima™ SC) first received European approval in November 2019 and was launched in the EU in 2020).  In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US.