Celltrion announced on June 3rd that it has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of a label extension for 'Remsima SC.' This extension includes additional dosing regimens and an increased dosage.

Remsima SC is a subcutaneous (SC) version of the autoimmune disease treatment infliximab, which was originally available as an intravenous (IV) formulation. Celltrion developed this SC version to provide a more convenient administration option. In the United States, it is marketed under the name 'Zymfentra.' This improved formulation, which offers the same efficacy and safety as the long-prescribed infliximab, has gained significant attention in the global market, surpassing annual sales of approximately $217 million last year.

To sustain this growth, Celltrion has secured CHMP's positive opinion for the approval of additional dosing regimens and an increased dosage for Remsima SC. This decision is based on global clinical trials conducted with patients suffering from Crohn's disease (CD) and ulcerative colitis (UC).

A new dosing regimen option has been added for CD and UC patients. The initial IV therapy involves three IV infusions, followed by the administration of Remsima SC from the 10th week. This supplements the existing regimen, where two IV infusions are followed by maintenance therapy with Remsima SC starting from the 6th week. This allows for customized treatment tailored to the patient's condition and therapeutic circumstances.

The dosage increase permits a higher dosage of up to 240 mg in the maintenance therapy with Remsima SC for CD patients, if necessary. This change is for patients who have experienced a decrease in efficacy after initially receiving 120 mg of Remsima SC, providing the option to increase the SC dosage. This adjustment is expected to improve treatment accessibility for patients who previously could not receive insurance coverage for the increased dosage as it was not reflected on the label.

A Celltrion representative stated, "The CHMP's positive opinion is effectively equivalent to an approval, as it plays a crucial role in the European Commission's (EC) final approval. With the approval of the label extension for Remsima SC, we can offer more flexible options and convenient self-administration opportunities to patients in Europe. We anticipate that healthcare professionals will increasingly prefer prescribing Remsima SC."