'Remsima SC' Targets Europe, Accelerates with Clinical Data Disclosure

2023 ECCO Clinical Results Presentation
Conversion RWD and Clinical Outcomes of Colitis and Crohn's Disease

The 2020 event of the European Crohn's and Colitis Organisation (ECCO), a leading European society for inflammatory bowel disease, is taking place.
[Photo by ECCO]

Celltrion Group will focus on showcasing the competitiveness of its leading autoimmune disease treatments, including 'Remsima SC' and 'Yuflyma,' at a conference held locally in Europe.

Celltrion Group announced on the 28th that it will participate in the 2023 European Crohn’s and Colitis Organization (ECCO) conference, held from the 1st to the 4th of next month (local time) in Copenhagen, Denmark, to introduce the competitiveness of its autoimmune disease treatments.

ECCO is a leading European inflammatory bowel disease (IBD) conference attended by more than 8,000 healthcare professionals (HCPs). The latest clinical research and trends in drug development related to these diseases are presented. Last year, Celltrion Group presented research results including investigator-initiated trials (IIT) on switching to Remsima SC and maintenance treatment clinical trials for Crohn’s disease (CD) patients.

Celltrion's autoimmune disease treatment 'Remsima SC'
[Photo by Celltrion]

At this year’s ECCO, Celltrion Group plans to focus on demonstrating the efficacy of Remsima SC. Remsima is a biosimilar of the autoimmune disease treatment 'Remicade' (generic name infliximab), a tumor necrosis factor (TNF)-alpha inhibitor. Celltrion first biosimilarized Remsima in an intravenous (IV) form as ‘Remsima IV’ and then successfully developed a bio-better in a subcutaneous (SC) form. To date, it is the only SC formulation product among both the original and biosimilars, and since SC generally offers greater convenience and safety compared to IV, it is emerging as a new treatment option. It has already obtained marketing approval in over 40 countries, including the Korean Ministry of Food and Drug Safety and the European Medicines Agency (EMA). Recently, it also applied for new drug approval after receiving guidance to proceed with the new drug approval process from the U.S. Food and Drug Administration (FDA).

Accordingly, Celltrion Group is focusing on expanding the market by positioning Remsima SC as a next-generation core strategic product. It has completed patent applications for formulation and administration methods in over 100 countries worldwide and is rapidly increasing its market share in Europe, leveraging the advantages of fast administration effects and formulation convenience. According to IQVIA, a pharmaceutical market research firm, as of the third quarter of last year, market shares have rapidly increased to 30% in Germany and 22% in Finland. In particular, the introduction of Remsima SC has created a virtuous cycle where prescriptions for both Remsima and Remsima SC are expanding through formulation synergy, with patients switching from other infliximab products to Remsima and then maintaining treatment with Remsima SC.

At this ECCO, Celltrion Group will present real-world switching data of Remsima SC conducted in Europe, as well as the first results of two new global phase 3 clinical trials of Remsima SC conducted on patients with ulcerative colitis (UC) and Crohn’s disease. Additionally, on the 3rd of next month during the conference, a symposium titled ‘Exploring Treatment Sequence in Inflammatory Bowel Disease with Subcutaneous Infliximab’ will be held.

Celltrion's biosimilar (biopharmaceutical generic) 'Uplima' 40mg 0.4ml [Photo provided by Celltrion]

Celltrion Healthcare will open a dedicated promotional booth locally and invite medical professionals to seminars, introducing the competitiveness of both Remsima SC and Yuflyma. In particular, an experience area will be set up within the booth where visitors can directly examine the devices (Trainer Kits) of Remsima SC and Yuflyma and freely access prepared data through a detailing touchscreen.

Yuflyma is a biosimilar of the autoimmune disease treatment 'Humira' and is the first Humira biosimilar approved by the EMA in a high-concentration formulation (HCF). It has received approval for all full-label indications held by Humira and is supplied in Europe. In the U.S., as issues with overseas manufacturing sites are nearing resolution, FDA approval is expected to be decided by May. Furthermore, Celltrion has entered a global phase 3 clinical trial to secure interchangeability between Humira and Yuflyma, aiming to strengthen its competitiveness further.

A Celltrion Group official stated, “Following Remsima, which has established a solid position in the European autoimmune disease treatment market, Remsima SC and Yuflyma are also continuing stable growth within the market. With efficacy and safety secured through global clinical trials and real-world data, we will spare no effort at the group level to enable more patients and healthcare professionals to access high-quality pharmaceuticals.”