Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC at ECCO 2024

At the Congress of European Crohn’s and Colitis Organisation (ECCO), Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease (CD) and ulcerative colitis (UC).

ECCO 2024 took place from February 21 to February 24, 2024, in Stockholm, Sweden.

Updated Celltrion Data on Subcutaneous Infliximab Therapy¹

Celltrion shared long-term data from its LIBERTY trials investigating the use of its subcutenous (SC) infliximab product (Zymfentra, Remsima SC) in Crohn disease (LIBERTY-CD) and ulcerative colitis (LIBERTY-UC). The company also touched on endoscopic outcomes from the LIBERTY-CD post hoc analysis.

In Europe, Remsima SC is considered an infliximab biosimilar. However, in the US, Zymfentra was approved as a novel infliximab agent because the FDA could not grant biosimilar status to the product when the reference agent (Remicade) does not have an SC presentation.

The extension phases of the LIBERTY-CD and LIBERTY-UC studies, which followed the initial LIBERTY trials, continued for up to 102 weeks to assess the long-term effectiveness and safety of CT-P13 SC in patients with CD and UC, respectively.

In the CT-P13 SC LIBERTY-CD study, 180 patients with moderate to severe active CD participated in the extension phase, receiving 120 mg of CT-P13 SC regardless of their previous treatment assignment. Of these, 154 (85.6%) completed the extension phase. In the CT-P13 SC LIBERTY-UC study, 237 patients with active UC entered the extension phase and received CT-P13 SC, irrespective of their initial treatment group. The study demonstrated sustained efficacy through week 102, with 208 (87%) patients completing the extension phase.

Both studies’ measures for evaluating clinical remission, clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were generally well maintained at week 102 compared with week 54. No new safety concerns were noted during the extension phase.

Jean Frédéric Colombel, MD, director of the Inflammatory Bowel Disease Center, Icahn School of Medicine at Mount Sinai, and the lead author of the poster presentation, stated, "These findings support the efficacy and safety of subcutaneous infliximab (CT-P13 SC) as a long-term treatment option for patients with moderately and severely active CD and UC. The combination of convenience and robust clinical data offers potential benefits for patients managing IBD."

Additionally, a post hoc analysis of the CT-P13 SC LIBERTY-CD study investigated endoscopic mucosal healing patterns across intestinal segments in patients who have CD receiving CT-P13 SC maintenance treatment. The analysis revealed consistent and high rates of endoscopic mucosal healing across all segments up to 1 year, including the terminal ileum, with CT-P13 SC maintenance therapy. Rates of both complete and partial endoscopic mucosal healing were significantly higher in the CT-P13 SC arm compared with placebo.

At ECCO 2024, 32 abstracts concerning CT-P13 SC were presented.

Samsung Bioepis Shares Ustekinumab Biosimilar Results²

Samsung Bioepis revealed data from 2 studies evaluating its ustekinumab biosimilar candidate (SB17) in relation to the reference product, Stelara. One study was an overview of analytical assessment results of SB17 compared with Stelara and the other evaluated the “totality-of-the-evidence” to support extrapolated of SB17 to Stelara.

The overall findings from the study established SB17 as being highly similar to the Europe- and US-sourced reference product in terms of structural, physiochemical, and biological attributes.

“The presentations we studied show our ongoing commitment to providing clinically proven biosimilars in terms of efficacy and safety to patients who need them and making physicians and patients confident on the use of biosimilar across indications,” said Hyejin Kim, vice president of medical and lifecycle safety team leader at Samsung Bioepis.

SB17 is the fourth biosimilar developed by Samsung Bioepis intended to treat immunology conditions. In September 2023, the company signed an agreement with Sandoz, allowing the latter to have exclusive commercialization and marketing rights for SB17 in the United States, Canada, the European Economic Area, Switzerland, and the United Kingdom.

References

1. Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress. News release. Celltrion. February 23, 2024. Accessed February 22, 2024.
2. Samsung Bioepis presents two abstracts for SB17, a proposed biosimilar to Stelara (ustekinumab), at the 19th Annual Congress of European Crohn’s and Colitis Organisation (ECCO). News release. Samsung Bioepis. February 22, 2024. Accessed February 22, 2024. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=373&currentPage=1