Celltrion Healthcare has secured approval from the European Commission (EC) for the subcutaneous (SC) formulation of autoimmune disease drug Remsima (infliximab, CT-P13) for the treatment of five more indications.
Remsima, which is an infliximab biosimilar, has now been indicated for the treatment of adults having ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis.
Its latest approval comes after a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) last month.
The expanded approval has been driven by data from a pivotal trial that evaluated the pharmacokinetics, efficacy, and safety of its SC and intravenous (IV) formulations in Crohn’s disease and ulcerative colitis.
Based on the findings of the study, a 120mg fixed dose of Remsima SC has been indicated for use in adults irrespective of body weight, in existing and newly added diseases.
University Hospital Schleswig-Holstein Kiel Campus Clinic for Internal Medicine director Professor Stefan Schreiber 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.
“Today’s 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.”
CT-P13 became the first monoclonal antibody biosimilar in the world to have been approved by the European Commission (EC). It was previously approved in the European Union for eight autoimmune diseases, which include rheumatoid arthritis and inflammatory bowel disease under the Remsima trade name in 2013.
In April 2016, CT-P13 under the trade name Inflectra was approved by the US Food and Drug Administration. The infliximab biosimilar has approval across more than 94 countries, including the US, Japan, Canada, and throughout Europe.
Celltrion Healthcare vice chairman Hyoung-Ki Kim said: “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.
“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.”