Celltrion's 'Remsima SC' Expands Patient Accessibility in Europe

Celltrion announced on the 4th that it has obtained final approval from the European Union (EU) Executive Commission (EC) for the addition of administration regimens and dosage increase for the autoimmune disease treatment drug RemsimaSC.

Remsima SC Model
Photo by Lee Chunhee

RemsimaSC is a drug containing infliximab, an autoimmune disease treatment ingredient that has been used for a long time and proven for efficacy and safety. Infliximab drugs have only been developed in intravenous (IV) injection form, which requires visiting medical institutions for administration, leading to a high unmet demand for the more convenient subcutaneous (SC) injection form. Celltrion's RemsimaSC is the first and only subcutaneous injection form drug developed among infliximab-containing drugs.

Leveraging this convenience, sales exceeded 300 billion KRW last year, and in the United States, after the Food and Drug Administration (FDA) first recommended a new drug approval application, it received new drug approval under the product name Gimpenetra and was launched in March.

The addition of administration regimens and dosage increase for RemsimaSC was carried out to enable optimized personalized prescriptions considering various patient conditions. First, in the administration regimen, an option was added for prescribing RemsimaSC after intravenous product administration for patients with inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. Previously, RemsimaSC was administered starting from week 6 after two intravenous injections, but now an additional regimen allows administration starting from week 10 after three intravenous injections.

The dosage increase allows increasing the dose up to 240 mg of RemsimaSC if necessary for Crohn's disease patients whose efficacy decreased after receiving 120 mg of RemsimaSC. Until now, dosage increases were not reflected on the label, so patients could not receive insurance benefits, but treatment accessibility for these patients is expected to improve.

A Celltrion official said, "The expansion of personalized prescriptions through administration regimen and dosage increases will further strengthen the competitiveness of RemsimaSC," adding, "This will lead to market share expansion and provide more flexible options and convenient self-administration opportunities for patients in Europe."