Current Edition

EC approves subcutaneous version of Remsima

The European Commission has authorised the world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis.

The authorisation for the subcutaneous (SC) formulation now applies to all previously approved indications for the intravenous (IV) formulation in adults including: ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis (PsO).

The SC formulation can be administered by patients themselves, reducing treatment time to approximately two-five minutes, with a comparable efficacy and safety profile to the IV formulation of the drug.

The approval follows a positive opinion from the European Medicines Agency human medicines committee 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 Crohn’s disease and ulcerative colitis, throughout a one-year treatment period.

Based on the results of the pivotal study, a 120mg fixed dose of Remsima SC has been approved for use in the EU, in adults regardless of body weight, in both existing and newly added indications.

“The approval of Remsima 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,” noted Professor Stefan Schreiber, director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany.

Hyoung-Ki Kim, vice chairman at Celltrion Healthcare, said the company will now “accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases.”

He added: “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.”