[July 27th 2020] - INCHEON, SOUTH KOREA Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohns disease, ulcerative colitis, psoriatic arthritis and psoriasis.[i]

The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima in people with active Crohns disease and ulcerative colitis, throughout a 1-year treatment period.[ii],[iii] Based on the results of the pivotal study, a 120 mg fixed dose of Remsima SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.

Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: The subcutaneous formulation of Remsima (Remsima SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. Todays approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.

We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis, said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We will do our best to make Remsima SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.

Celltrion anticipates receiving approval of Remsima SC in 97 countries, including 31 countries in Europe.

[i] European Medicines Agency Summary of Product Characteristics (SmPC). Remsima.

[ii] Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohns disease. European Crohns and Colitis Organisation 2019. Abstract no: A-1103.

[iii] Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohns disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020.

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European Commission grants marketing authorisation for world's first subcutaneous formulation of infliximab, Remsima SC, for an additional five indic...