European Commission expands treatment use for Remsima SC to cover Crohn's disease and ulcerative colitis

Celltrion said it received approval from the European Commission (EC) for an additional administration method and increased dosing for Remsima SC (ingredient: infliximab), an autoimmune disease treatment for Crohn's disease (CD) and ulcerative colitis (UC).

Remsima SC is the world's first subcutaneous (SC) form of the autoimmune disease treatment infliximab, which was previously available only as an intravenous (IV) formulation.

The approval is based on global clinical trials conducted on patients with CD and UC.

In the administration method, an initial IV treatment for CD and UC patients has been added, where IV is administered three times, followed by Remsima SC starting from the tenth week.

Celltrion said this provides an alternative to the existing method of administering IV twice and then starting Remsima SC maintenance therapy from the sixth week, allowing for more customized treatment based on the patient's condition and treatment circumstances.

The dosing increase permits an increase in the maintenance therapy dose of Remsima SC for CD patients if needed.

Patients who have shown decreased efficacy after receiving the existing Remsima SC 120mg can now be administered up to 240mg.

The company expects this change is expected to improve treatment accessibility for patients who were previously unable to receive insurance benefits due to the lack of increased dosing reflected on the label.

With the new approval, the company aims to strengthen the influence of the Remsima product line in Europe further.

According to IQVIA, a drug market research firm, Remsima SC recorded a 21 percent market share in the top five European countries (EU5) – Germany, Spain, U.K., Italy, and France -- as of the fourth quarter of last year.

The combined market share of the Remsima and Remsima SC product lines in the EU5 stands at 74 percent.

"The expansion of personalized prescriptions due to the additional administration methods and increased dosing will strengthen the competitiveness of Remsima SC, leading to an increased market share," a company official said. "We can now provide European patients with more flexible choices and the opportunity for convenient self-administration."