Celltrion said Tuesday that it has presented the results of phase 3 clinical trials for Remsima (Ingredient: Infliximab), at the United European Gastroenterology Week.
Remsima is a monoclonal antibody biosimilar used for the treatment of autoimmune diseases, such as Crohn's disease.
The clinical trial randomly divided 220 patients with Crohn's disease into four groups -- Remsima, the original drug, the replacement of Remsima with the original drug, and replacement of the original drug with Remsima -- for a year.
The efficacy and safety of each group were compared and analyzed by criteria such as Crohn's Disease Activity Index, clinical remission and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score, a measure of the quality of life for people with inflammatory bowel disease, and they were similar in all the four groups, the company said.
The safety profiles among all treatment groups, including adverse reactions, serious adverse events, infections, and immunogenicity, were also similar throughout the one year treatment period.
"The result of the clinical trial demonstrates the long-term efficacy and safety in treating Crohn's disease patients with Remsima," said Alex Kudrin, vice-president of Celltrion. "The efficacy and safety of both groups that either replaced Remsima with the original drug or the original drug with Remsima were the same.”
The company 셀트리온 also presented phase 1 clinical trials for the subcutaneous injection version of Remsima at the conference.
Clinical results have proved a single dose of the subcutaneous injection provided therapeutic drug exposure comparable to the approved intravenous dosage form along with the safety of the administration.
"As a result of the accumulation of patient data on Remsima, various clinical trials are being presented by medical staffs around the world,” a company official said. “With the announcement of noteworthy clinical data demonstrating Remsima's equivalent efficacy and safety compared to the original drug, the reliability of Remsima has expanded not only to the opinion leaders in the medical community but also to ordinary doctors.”
Once the subcutaneous injection of Remsima is commercialized, medical personnel can freely choose between the injection and intravenous dosage in consideration of the patient's condition, he added.