"Remsima SC, Seo Jung-jin's Idea... Will Enter US Market as a New Drug"

[ECCO 2023]
Interview with Kim Seong-hyun, Head of Medical Division at Celltrion

"Biosimilar as the First Case of New Drug Approval"
Chairman Seo Directly Leads Development in Response to Local Medical Staff Demands

Kim Sung-hyun, Head of Medical Affairs at Celltrion, met at the Bella Center in Copenhagen, Denmark, where the European Crohn's and Colitis Organisation (ECCO 2023) was held.
[Photo by Lee Chun-hee]

Celltrion's 'Remsima IV (active ingredient infliximab)' established the concept of biosimilars as the world's first 'antibody biosimilar (biopharmaceutical copy)'. Celltrion did not stop there and introduced 'Remsima SC', the first subcutaneous (SC) formulation of infliximab, and is continuing its pioneering role by challenging the U.S. Food and Drug Administration (FDA) approval process for new drugs.

We met Kim Seong-hyun, Head of Medical Affairs (Director) at Celltrion, who leads Celltrion's research and development (R&D), on the 2nd (local time) at the Bella Center in Copenhagen, Denmark, where the European Crohn's and Colitis Organisation (ECCO 2023) was held. He said, "(If FDA approval is granted) it will be the world's first case of a biosimilar being approved as a new drug," adding, "It will likely remain a unique case going forward."

Remsima SC has been approved as a biosimilar by the Korean Ministry of Food and Drug Safety and the European Medicines Agency (EMA). However, in December last year, Celltrion applied for FDA approval of Remsima SC as a new drug following consultations with the FDA. Kim said, "Biosimilars face pricing issues due to competition, but new drugs have less influence and interference from competing products and offer higher added value," forecasting significant advantages in market entry.

Celltrion secured efficacy and safety results from global Phase 3 clinical trials for inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). Detailed information was disclosed for the first time through a paper at ECCO. Kim recalled, "Since it is not a common disease, the clinical trials were not easy," but added, "Fortunately, the clinical results were good." The biggest challenge was the control group. Unlike typical biosimilar trials where the original drug is administered to the control group, this trial was for new drug approval, so a placebo group was set as the control. Kim explained, "It was difficult because we could not give an effective drug to patients," and "The trial was designed ethically and safely so that the control group could receive treatment whenever necessary."

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

Outside the U.S., Remsima SC has secured full-label indications covering all original indications. However, Celltrion applied to the FDA for indications only for Crohn's disease and ulcerative colitis. Kim said, "In the U.S., we will only seek indications for IBD," and regarding other indications, "We could pursue them if necessary, but we have no immediate plans for clinical trials." Despite many SC formulation drugs for IBD with other active ingredients, infliximab has maintained its market presence based on efficacy with only an intravenous (IV) formulation. Celltrion's strategy is to solidify its influence in the IBD market by offering both IV and SC portfolios simultaneously.

Kim also mentioned that the origin of Remsima SC traces back to Celltrion Honorary Chairman Seo Jung-jin. When Seo asked local European medical professionals about inconveniences, he heard that there was no SC formulation, which led to the development. During the European approval process, local medical professionals submitted petitions to relevant authorities stating that the SC formulation would enhance medical convenience, reflecting strong demand from the field. Kim said, "There was much internal opposition," and "Although there were many challenges during the clinical process, the clinical results ultimately turned out well." If Remsima SC is approved as a new drug by the FDA, it is expected to receive patent protection until 2038, 15 years later.

The benefits of switching to Remsima SC include convenience and stable efficacy. Kim explained, "The biggest market for other active ingredients in IBD is due to convenience (of the SC formulation)," and "Remsima SC now offers a new option for new patients." Given the nature of IBD, where quickly raising drug concentration early to suppress symptoms is important, Remsima's potential is significant by providing various options to use IV for the 'loading period' followed by SC for maintenance therapy.

Regarding efficacy, he emphasized, "It is a formulation that maintains safety equivalently while resolving the issue of blood concentration decline." IV administration every 8 weeks causes a rapid increase in blood concentration immediately after dosing, but the concentration drops and may fall below the appropriate level just before the next dose. In contrast, SC administration every 2 weeks allows for stable maintenance of blood concentration.

This content was produced with the assistance of AI translation services.