Celltrion: "No Difference in Formulation for Remsima SC"

[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 27th the results of a Phase 3 clinical trial confirming the efficacy of the subcutaneous injection for autoimmune disease treatment, 'RemsimaSC' (generic name infliximab), in treating rheumatoid arthritis and its non-inferiority compared to the intravenous (IV) formulation.

In this clinical trial, 343 rheumatoid arthritis patients were divided into two groups and administered Remsima IV and subcutaneous (SC) formulations respectively for up to 30 weeks. Afterwards, all patients received RemsimaSC biweekly up to 54 weeks.

The administration results showed that both groups developed antibodies significantly, and it was proven that there was no difference in immunogenicity depending on the formulation.

Additionally, three posters were presented together, including the one-year results of patients who switched from the existing Remsima IV formulation to RemsimaSC, the usability of RemsimaSC, and the evaluation of the impact of patients' body mass index (BMI) on efficacy.

Professor Yoo Dae-hyun of Hanyang University Rheumatism Hospital, who gave the oral presentation of the Phase 3 clinical trial results, stated, "The evaluation of drug efficacy and safety in the patient group prescribed RemsimaSC confirmed its non-inferiority to the existing Remsima," adding, "We concluded that RemsimaSC is a highly convenient treatment option for patients with autoimmune diseases such as rheumatoid arthritis."