Celltrion to Present New ZYMFENTRA® Data for IBD Management at 2025 Digestive Disease Week
Key Insights
Celltrion will present six abstracts at the 2025 Digestive Disease Week, featuring post-hoc analyses and real-world evidence for ZYMFENTRA (search)®, the first FDA-approved subcutaneous infliximab.
The presentations will highlight ZYMFENTRA (search)'s performance across diverse patient populations with moderate-to-severe Crohn's disease (search) and ulcerative colitis (search), addressing individualized treatment approaches.
These data reinforce Celltrion's commitment to providing comprehensive clinical evidence to healthcare professionals for informed treatment decisions in the evolving IBD landscape.
Celltrion, Inc. announced today that it will present six abstracts at the upcoming 2025 Digestive Disease Week® (DDW) Annual Meeting, taking place May 3-6 in San Diego, California. The presentations will showcase new data on ZYMFENTRA (search)® (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab for inflammatory bowel disease (search) (IBD).
The oral and poster presentations will feature post hoc analyses of Celltrion's pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) as well as real-world evidence supporting the use of ZYMFENTRA (search) in clinical practice.
"We are excited by the opportunity to present further analyses reinforcing ZYMFENTRA (search)'s clinical value for HCPs and patients," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA (search). "With IBD management becoming increasingly individualized, we anticipate these analyses will help clarify how ZYMFENTRA performs across a wide range of patient types, from long-term drug persistence to recapture following dose escalation."
Advancing Personalized IBD Treatment
The new data comes at a critical time when IBD management is evolving toward more personalized approaches. ZYMFENTRA (search) represents a significant advancement as the first subcutaneous formulation of infliximab, offering patients an alternative to intravenous administration for maintenance therapy.
The presentations will provide healthcare professionals with valuable insights into ZYMFENTRA (search)'s efficacy and safety profile across different patient populations with moderate-to-severe Crohn's disease (search) and ulcerative colitis (search). This information is expected to support clinical decision-making in the long-term management of these chronic conditions.
Expanding the Evidence Base for Subcutaneous Infliximab
ZYMFENTRA (search) was approved by the FDA through the Biologics License Application (BLA) under the 351(a) pathway of the Public Health Service Act as a "stand-alone" BLA. The drug is considered a new biologic with patent protection for its dosage form until 2037 and for its route of administration until 2040.
As a TNF-alpha (search) inhibitor, ZYMFENTRA (search) blocks a protein that can be overproduced in response to certain diseases, causing the immune system to attack normal, healthy parts of the body. The drug is indicated for maintenance treatment in adults with moderately-to-severely active Crohn's disease (search) or ulcerative colitis (search) following initial treatment with an intravenous infliximab product.
Clinical Implications for IBD Management
The abstracts being presented at DDW 2025 are expected to provide new insights into several key aspects of ZYMFENTRA (search) therapy:
- Long-term drug persistence in real-world settings
- Efficacy in patients who require dose escalation
- Safety profiles across different patient populations
- Comparative effectiveness with other treatment modalities
These findings will be particularly relevant for gastroenterologists and IBD specialists who must navigate an increasingly complex treatment landscape with multiple biologic and small molecule options.
About Digestive Disease Week®
Digestive Disease Week® is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. The 2025 meeting will showcase more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology.
The event is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
About Inflammatory Bowel Disease
Inflammatory bowel disease (search), which includes Crohn's disease (search) and ulcerative colitis (search), affects millions of people worldwide. These chronic conditions are characterized by inflammation of the gastrointestinal tract, leading to symptoms such as abdominal pain, diarrhea, fatigue, and weight loss.
Despite advances in treatment options, many patients continue to experience disease flares and complications that significantly impact their quality of life. The development of subcutaneous formulations of established therapies like infliximab represents an important step in improving treatment convenience and potentially enhancing adherence.
About Celltrion
Celltrion is a leading biopharmaceutical company specializing in researching, developing, manufacturing, and marketing innovative therapeutics. The company is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar.
Celltrion USA (search), the company's U.S. subsidiary established in 2018, is committed to expanding access to innovative biologics for U.S. patients. The company's FDA-approved portfolio includes products in immunology, oncology, hematology, and endocrinology.
The presentations at DDW 2025 reflect Celltrion's ongoing commitment to advancing scientific understanding in the field of IBD and supporting healthcare professionals with comprehensive clinical and real-world evidence to inform treatment decisions.