Celltrion has presented the phase 3 clinical trial result for Remsima SC, the subcutaneous (SC) version of infliximab biosimilar, at the 2019 European League against Rheumatism (EULAR 2019) from June 12-15 in Madrid.
|Celltrion Healthcare’s booth in EULAR 2019 at the Institución Ferial de Madrid in Madrid, Spain|
The results of clinical phase 1 and 3 of Remsima SC drew industry’s attention by containing comprehensive clinical results on its efficacy and safety.
"We concluded that Remsima SC could be another convenient prescription option for rheumatoid arthritis patients," the company said. "Clinical results of 362 rheumatoid arthritis patients showed similar safety results between Remsima SC and Remsima (intravenous IV) administration until week 30."
In terms of efficacy, both the American College of Rheumatology and ULAR response rate of the Remsima SC group were slightly higher than those of the Remsima group, confirming the non-inferiority of Remsima SC, it said.
During the conference, the company also published a post-marketing study that analyzed the long-term safety of Remsima, by examining about 1,500 patients who have rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis among 4,400 real-world data of Remsima's global prescription.
Celltrion confirmed that Remsima's major safety profile -- severe infection and tuberculosis -- is comparable to the results of several studies on original drugs.
With such results, the EU's Committee for Medicinal Products for Human Use (CHMP) has confirmed that the company has met its post-authorization commitments.
According to the Celltrion, the company also received favorable comments from local medical practitioners because it raised the level of confidence in the products by ending the dispute over biosimilar safety. The dispute has been raised as a defense strategy from original drug developers, by utilizing actual patient prescription data.
"By presenting the results of Remsima SC, we have succeeded in proving the viability of Remsima's dual-formulation treatment strategy," said Lee Sang-joon, vice president of Celltrion's clinical development division.
The company plans to market Remsima, which had a market share of 57 percent in the European market four years after its launch, and Remsima SC and cultivate them into a global blockbuster product that can surpass the original drug, Lee added.