On 11 March 2026, Celltrion announced the European launch of its Remsima® IV liquid formulation, biosimilar to Janssen’s Remicade® (infliximab). This follows the November 2025 approval of Remsima® IV liquid formulation by the European Commission for the treatment of rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
The company has completed patent registrations in most European countries including the UK, Germany and France. Celltrion has secured national tenders in Denmark and Norway for the Remsima® IV liquid formulation, with sales expected to commence in Norway immediately following the contract award.
The launch of the IV liquid formulation of infliximab aligns with Celltrion’s broader strategy of focusing on formulation-based differentiation announced earlier this year. This launch completes Celltrion’s full line up of infliximab products, which includes the world’s first subcutaneous infliximab solution product and an IV powder formulation.
Remsima® IV powder formulation was first approved in Europe in 2013 and launched across major European countries in early 2015. The subcutaneous formulation, Remsima® SC, received European approval in 2019 and was launched in the EU in 2020. In February 2024, Celltrion launched Remsima® SC in the US under the brand name Zymfentra®.
Several other infliximab biosimilars have been approved around the world, including Hospira/Pfizer/Celltrion’s Inflectra® in the EU, Canada, New Zealand and USA; Samsung Bioepis’s Flixabi® in the EU and Renflexis® in Australia, New Zealand and the USA; Pfizer’s Ixifi® in Australia, New Zealand and the USA; Biocad’s BCD-055 in Russia; Sandoz’s Zessly® in the EU; and Amgen’s Avsola® in the USA.