Europe Enthralled by 'Remsima SC', Overcomes First Hurdle in US New Drug Approval Process

[ECCO 2023]
Phase 3 Clinical Trial Results for New Drug Approval Announced
Strong Interest Confirmed in Europe
Efficacy Maintained... Patient Burden Reduced by Half

'Remsima SC' educational model displayed at the Celltrion Healthcare booth set up at the European Crohn's and Colitis Organisation (ECCO 2023) event venue
Photo by Lee Chunhee

"Infliximab SC showed superiority over other formulations in improving maintenance therapy for patients with inflammatory bowel disease (IBD)." (Walter Reinisch, Professor at Medical University of Vienna, Austria)

"Although infliximab is an old drug, it remains the best ingredient. 'Remsima SC' will continue to attract attention considering the increasing number of IBD patients." (Milan Lukas, Professor at Charles University and ISCARE Hospital, Czech Republic)

Celltrion announced two new Phase 3 clinical trial results of 'Remsima SC (active ingredient infliximab)' at the European Crohn's and Colitis Organisation (ECCO 2023) held from April 1 to 4 (local time) at the Bella Center in Copenhagen, Denmark, marking its readiness to advance beyond biosimilars to new drugs.

This clinical trial was conducted to demonstrate the efficacy of Remsima SC as maintenance therapy for patients with Crohn's disease (CD) and ulcerative colitis (UC), the main diseases of autoimmune inflammatory bowel disease (IBD). It was a critical hurdle for Celltrion, which applied for new drug approval of Remsima SC after consultation with the U.S. Food and Drug Administration (FDA), but both clinical trials were successful.

First, in the clinical trial involving 343 Crohn's disease patients conducted up to week 54, the primary endpoint, clinical remission defined as Crohn's Disease Activity Index (CDAI) below 150, was observed in 62.3% of the treatment group compared to 32.1% in the placebo group, and endoscopic response was 51.1% in the treatment group versus 17.9% in the placebo group. Statistical significance was also demonstrated. Additionally, good results were confirmed in secondary endpoints and safety.

Similarly, in the clinical trial involving 438 ulcerative colitis patients conducted up to week 54, clinical remission regarding symptoms such as stool frequency and rectal bleeding was observed in 43.2% of the treatment group compared to 20.8% in the placebo group. This also achieved positive outcomes in secondary endpoints and safety.

On the 2nd (local time), at the Celltrion Healthcare booth set up at the European Crohn's and Colitis Organisation (ECCO 2023) held at the Bella Center in Copenhagen, Denmark, Professor Milan Lukas of Charles University in the Czech Republic (Director of Iscare Hospital) gave a presentation on Remsima SC during the "Meet the Experts" event. According to Celltrion Healthcare, about 170 people gathered that day to listen attentively to Professor Lukas's presentation.
[Photo by Lee Chunhee]

Local experts unanimously agreed that Remsima SC showed good efficacy. Professor Lukas, who had shown interest since Remsima was sold as an intravenous (IV) injection, stated, "Remsima SC maintains stable blood drug concentrations, making it effective for IBD treatment," and predicted, "It will continue to attract attention." Maintaining appropriate drug concentration is essential for sustained therapeutic effect, but IV dosing intervals of 8 weeks raised concerns about drug levels falling below the optimal range before re-administration. However, SC administration every 2 weeks frees patients from such concerns, allowing more stable treatment.

Consequently, the high local interest in Remsima SC was palpable. Crowds filled every venue where related presentations were held. At the 'Meet the Expert' event held over two days at the Celltrion Healthcare booth, more than 170 people attended each session to listen to the presentations. Byungseo Choi, Head of Marketing at Celltrion Healthcare, said, "The second presentation was in the morning, yet more people attended than the previous day," adding, "Considering that booth presentations usually do not attract large crowds, this was unusual."

Celltrion Group also made extensive efforts throughout ECCO, effectively treating it as a launch event for U.S. new drug approval. Celltrion Healthcare was listed as a 'corporate member' alongside big pharma companies such as Pfizer, Roche, and Janssen on the conference sponsorship list, and the lanyards provided to all attendees were supplied by Celltrion Healthcare.

Additionally, in Hall C, where pharmaceutical and biotech companies had exhibition booths, Celltrion installed a large booth near the entrance for extensive promotion. Educational models of products such as Remsima SC and 'Uplima,' which Celltrion Group is actively targeting for new markets, were displayed, providing a space for direct product experience.

Celltrion Healthcare made various promotional efforts at the European Crohn's and Colitis Organisation Congress (ECCO 2023), including setting up a large booth at the exhibition hall and providing lanyards with the conference entrance badges.
[Photo by Lee Chunhee]

Celltrion plans to complete FDA approval of Remsima SC within this year and target the U.S. market by emphasizing convenience and stable efficacy. Seonghyun Kim, Head of Medical Affairs at Celltrion, who was met locally, explained, "Remsima SC offers patients a new option," adding, "It is a formulation that resolves blood concentration decline while maintaining equivalent safety."

Using Remsima SC is also expected to significantly reduce patients' economic burden. Crohn's disease and ulcerative colitis have no cure and require continuous treatment, making them diseases with high treatment costs for patients. Although simple comparisons are difficult due to regional differences, the self-administration capability of the infliximab SC formulation is expected to greatly reduce costs related to IV administration and outpatient visits.

Previously, in 2021, a study published in the UK predicted that the introduction of infliximab SC would reduce annual total costs by about half. At this ECCO, Celltrion Healthcare also presented a study estimating that the introduction of the SC formulation in Latvia could reduce costs by 1.03 million euros (approximately 1.4 billion KRW) over five years compared to not introducing it.