Celltrion Promotes the Excellence of Remsima SC and Uplyma in Europe

Celltrion announced on the 21st that it will participate in the ‘2024 European Crohn’s and Colitis Organisation (ECCO)’ held in Stockholm, Sweden from the 21st to the 24th (local time), introducing autoimmune disease treatments such as Remsima SC and Upalima to local experts and emphasizing their competitiveness.

At the 'Meet the Experts' event held at the Celltrion Healthcare booth during the European Crohn's and Colitis Organisation (ECCO 2023) conference in Copenhagen, Denmark, last February, Milan Lukas, professor at Charles University in the Czech Republic and director of Iscare Hospital, gave a presentation on Remsima SC. According to Celltrion Healthcare, about 170 people gathered that day to listen to Professor Lukas's presentation.
[Photo by Lee Chunhee]

ECCO is a leading European inflammatory bowel disease conference attended by more than 8,000 medical professionals annually. The latest clinical research and trends in drug development related to these diseases are presented.

At this ECCO, Celltrion plans to unveil for the first time a poster presenting the long-term efficacy and safety results of the global Phase 3 clinical trial of Remsima SC conducted on patients with ulcerative colitis and Crohn’s disease. The data covers 102 weeks of Remsima SC maintenance therapy, reflecting clinical outcomes of patients treated for about two years. Additionally, Celltrion will present post-analysis results of the global Phase 3 trial of Remsima SC, including real-world data (RWD) related to switching to Remsima SC.

Celltrion will set up a dedicated promotional booth on site and hold seminars to highlight the therapeutic effects and competitiveness of Remsima SC switching as experienced by European medical professionals in actual clinical settings. On the 22nd, a symposium titled “Endoscopic Treatment Achievement with Infliximab Subcutaneous Formulation for Inflammatory Bowel Disease: A Journey Toward Improving Long-term Treatment Outcomes” will also be held.

Remsima SC is the first infliximab-based drug developed in a subcutaneous injection form in the tumor necrosis factor (TNF)-alpha inhibitor market for autoimmune disease treatment. Previously, infliximab could only be administered intravenously, requiring patients to visit hospitals, but with the development of Remsima SC, patients can self-administer the drug anywhere, greatly improving convenience.

Based on these strengths, Remsima SC achieved approximately 20% market share in the five major European countries?Germany, the United Kingdom, France, Italy, and Spain?as of the third quarter of last year. When combined with the intravenous formulation Remsima, the infliximab market share in these countries rises to 72%.

Furthermore, Celltrion is accelerating the entry of Remsima SC into the U.S. market. The U.S. Food and Drug Administration (FDA) granted new drug approval last October, recognizing the advantages of the formulation change, and the product will be launched under the name Zimpenetra on the 29th. As a new drug, it can be priced higher than existing biosimilars, and if the currently filed patents are granted, patent protection and revenue are expected until 2040.

At this ECCO, Celltrion will also actively promote the competitiveness of another autoimmune disease treatment, Upalima. It is the first high-concentration biosimilar among Humira biosimilars, approved and marketed in Europe and the U.S. for all indications held by Humira. To facilitate more active sales, at the end of last year, clinical trials were conducted to establish interchangeability between Humira and Upalima, proving equivalence between the two drugs, and a change approval application was submitted to the FDA last month.

A Celltrion official said, “As global clinical data continues to accumulate, the competitiveness of Remsima SC, which offers therapeutic efficacy and dosing convenience, is increasing. With rapid growth in Europe, expectations for Zimpenetra’s upcoming U.S. launch are also rising.”

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