Phase 3 clinical tests show biosimilar’s efficacy in treating Crohn’s disease

Celltrion has secured additional grounds for its biosimilar Remsima, called Infliximab in the United States, targeting the world’s largest pharmaceutical market.

The Korean biopharmaceutical company said Wednesday that it had obtained the results of phase 3 clinical trials and observational studies of Remsima, in comparison with the original drug, Johnson & Johnson’s Remicade, on the patients of Crohn's disease, which is an inflammatory bowel disease of sorts.

Celltrion and its distributor in the U.S. market, Pfizer, jointly invested in these clinical trials conducted in some severe cases of Crohn’s disease, it said.

Phase 3 clinical trials by Celltrion and Pfizer show biosimilar Remsima has sufficient efficacy and safety for Crohn’s disease.

More specifically, they did the tests on 220 patients aged 18-75 in 16 countries and analyzed the efficacy and safety results for up to 30 weeks.

As a result, all indicators have proved the similarity in the efficiency and safety of Remsima and its original drug.

Researchers gave six doses of Remsima or Remicade to two groups of patients with Crohn's disease and measured the Crohn's Disease Activity Index (CDAI), calprotectin concentration of their faces that indicate the inflammatory levels of intestines, and the C-reactive protein (CRP) levels.

The results of the study compared the clinical effects of Remsima and the original drug, along with the comparison of safety, the infection, the IV response and the immunogenicity.

Celltrion expects its distribution partner Pfizer will be able to step up its U.S. marketing based on these clinical results.

"We performed the trials to secure more grounds marketing Remsima in the U.S.,” a Celltrion official said. "Already, Remsima is the only infliximab biosimilar sold in the world's largest biopharmaceutical market. We will accelerate expanding our market share by strengthening clinical data that differentiate our product from second movers."

A researcher backed him up. "The severity of the disease and the age of the patients who participated in the clinical course of the Crohn's disease were very similar to the actual clinical situation," said Professor Kim Young-ho of Sungkyunkwan University, who took part in the tests.

“We found little differences from the original drug regarding efficacy and safety by prescribing Remsima to patients with inflammatory bowel disease,” He said. “We hope that more patients suffering from Crohn’s disease will be able to prescribe Remsima with confidence.”

The researchers presented their clinical results at the Digestive Disease Week (DDW) conference in Chicago, which closed Tuesday.

In the conference, the researchers also unveiled the results of the observational study and “switching study” with the original drug. The observational study involved 204 adult patients and 74 pediatric patients with Crohn's disease and ulcerative colitis, while the subjects of the switching study were 2,150 patients in six European countries, including Norway, Italy, and France, with inflammatory bowel disease.

"All these studies have proved doctors can prescribe Remsima instead of the original medicine," the Celltrion official said. "This clinic trail is the world's only randomized controlled clinical trials comparing biosimilars with the original drug, receiving much attention from various countries."

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