The European Commission has approved an under-the-skin injectable formulation of Remsima (infliximab) to treat patients with the two most common forms of inflammatory bowel disease (IBD) — ulcerative colitis and Crohn’s disease.
Celltrion Healthcare plans to make its subcutaneous formulation, referred to as Remsima SC, available to patients in the EU as quickly as possible. The company also anticipates that it will be approved in 97 countries worldwide.
“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 of Celltrion, said in a 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.”
One major advantage of Remsima SC is a significantly shorter time to administer the treatment compared to the previously-approved intravenous (injected into the blood stream) formulation, called Remsima IV.
Remsima SC takes two to five minutes to be administered, whereas Remsima IV requires a two-hour infusion process, followed by an additional one to two hours of patient monitoring.
This convenience is particularly relevant during the COVID-19 pandemic, as a reduction in the time spent administering a treatment could ultimately reduce the risk of viral transmission.
Infliximab, the active ingredient in Remsima, is a monoclonal antibody that binds to and reduces the activity of a protein called tumor necrosis factor alpha, which is involved in autoimmune responses and inflammation.
Remsima IV was first approved in Europe for inflammatory conditions in 2013, and later approved by the U.S. Food and Drug Administration in 2016 under the brand name Inflectra.
A recent Phase 1 clinical trial (NCT02883452) demonstrated that Remsima SC had comparable safety and efficacy to Remsima IV in patients with Crohn’s disease and ulcerative colitis.
These findings led to a positive opinion by the Committee for Medicinal Products for Human Use, a branch of the European Medicines Agency, which supported the recent marketing authorization by the European Commission.
“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,” said Stefan Schreiber, MD, PhD, professor at the University Hospital Schleswig-Holstein.
“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.
Unlike Remsima IV, which is administered at a dosage that is dependent on the weight of the patient (3 mg/kg), Remsima SC comes at a fixed dose of 120 mg. Three options are available to administer Remsima SC: a pre-filled pen (auto injector), a pre-filled syringe, or a pre-filled syringe with needle safeguard.
Remsima is considered a biosimilar, meaning that it is a biologic product similar and as effective as an approved reference product. In this case, Remsima was modeled after Remicade (infliximab), a biologic developed by Janssen.