EU Approves Under-the-skin Remsima Injectable for 5 Autoimmune Disorders

An under-the-skin injectable formulation of Remsima (infliximab), called Remsima SC, has been approved in European Union for the treatment of five autoimmune disorders, including ankylosing spondylitis.

The approval by the European Commission also covers Crohn’s disease, ulcerative colitis, psoriatic arthritis, and psoriasis, and follows a recent positive opinion from the Committee for Medicinal Products for Human Use, a branch of the European Medicines Agency.

“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,” Hyoung-Ki Kim, vice chairman at Celltrion Healthcare, which developed the treatment, said in a press release.

“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,” 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.”

Remsima is a biosimilar of Remicade (by Janssen), which was approved to treat ankylosing spondylitis in 2004. A biosimilar refers to a biologic medicine (one made using living cells) that works very similarly to a previously approved therapy, called a reference therapy. Similar to what generics are to conventional medications, biosimilars are usually sold at lower prices than their reference therapies.

Both Remsima and Remicade consist of a monoclonal antibody called infliximab. This antibody binds to tumor necrosis factor-alpha (TNF-alpha), a signaling molecule that drives inflammation. By binding TNF-alpha, infliximab can reduce the inflammation that characterizes ankylosing spondylitis and other autoimmune diseases.

Remsima and Remicade are both administered by intravenous (into-the-bloodstream) injection. With the new approval, which covers a dose of 120 mg regardless of body weight, Remsima is the only approved version of infliximab to have both intravenous and subcutaneous versions. This under-the-skin option shortens administration time from two hours to less than five minutes.

The new approval was based on data from a Celltrion-sponsored Phase 1 clinical trial (NCT02883452), which compared Remsima SC with Remsima administered intravenously in 181 patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis). Remsima was administered via a two-hour intravenous infusion every eight weeks; Remsima SC was given as a single injection every two weeks.

Results showed that both formulations were safe and effective at reducing disease activity. At the end of the study, blood levels of the medication were similar, regardless of formulation.

“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 [intravenous] formulation,” said Stefan Schreiber, MD, PhD, a professor at the University Hospital Schleswig-Holstein in Germany.

“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,” he added.