EC Grants Marketing Authorization for Remsima

Celltrion Healthcare has announced in a July 27, 2020 press release, that the European Commission (EC) has granted marketing authorization for its subcutaneous (SC) formulation of Remsima (infliximab, CT-P13).

Remsima SC is now approved for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and psoriasis, making it the only infliximab to have both intravenous (IV) and SC formulations approved. The marketing authorization follows from the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2020.

The approval has been based on data from a pivotal study that compared the pharmacokinetics, efficacy, and safety of the SC and IV formulations of Remsima in patients with Crohn’s disease and ulcerative colitis, during a treatment period of one year. Using the study data as guidance, the European approval has been granted for a 120-mg fixed dose of Remsima SC in adults, regardless of body weight, in existing and new indications.

“The subcutaneous formulation of Remsima (Remsima SC) has been shown to have very high efficacy, and favorable data, which are fully comparable to the efficacy and safety profile of the IV formulation,” said professor Stefan Schreiber, director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany, in the press release. “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.” 

“We are pleased to announce this important regulatory milestone earlier than we expected, with the EC prioritizing 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,” added Hyoung-Ki Kim, vice chairman at Celltrion Healthcare, in the press release. “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.”

Source: Celltrion Healthcare