Zymfentra (infliximab-dyyb subcutaneous) / Celltrion - LARVOL DELTA

Celltrion expands footprint in Italy with continued wins for autoimmune…drugs (Korea Biomedical Review) - "Celltrion’s Italian subsidiary recently won additional tenders for its ustekinumab biosimilar, Steqeyma, in the Veneto, Trentino-Alto Adige, and Sardinia regions, following earlier contracts in four regions this year...The company will supply the drug to seven regions in total through May 2026...Remsima IV won a recent tender in Umbria, while Remsima SC renewed its contract in Puglia, extending supply through May 2027...Celltrion’s adalimumab biosimilar Yuflyma is also gaining traction, with sales underway in Lazio and Umbria under contracts that will run for the next two to three years."

Commercial • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

SIC2: Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease (clinicaltrials.gov) - P=N/A | N=22 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Active, not recruiting ➔ Completed

Trial completion • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

CHARACTERISATION OF PATIENTS WHO EXPERIENCE LOSS OF RESPONSE DURING MAINTENANCE TREATMENT WITH SUBCUTANEOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE 2-YEAR PHASE 3 LIBERTY-CD AND LIBERTY-UC TRIALS (UEGW 2025) - No abstract available

Clinical • P3 data • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SWITCHING TO SUBCUTANEOUS INFLIXIMAB IMPROVES WORK PRODUCTIVITY IN PATIENTS WITH IBD: THE BIO-BETTER SWITCH STUDY (UEGW 2025) - No abstract available

Clinical • Inflammatory Bowel Disease

SWITCHING TO SUBCUTANEOUS INFLIXIMAB FOR REGAINING CLINICAL REMISSION IN IBD PATIENTS WHO LOST RESPONSE TO INTRAVENOUS INFLIXIMAB: AN OBSERVATIONAL STUDY FROM THE ENEIDA REGISTRY (UEGW 2025) - No abstract available

Clinical • Observational data • Inflammatory Bowel Disease

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN'S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY (UEGW 2025) - No abstract available

Clinical • Observational data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

INTRAVENOUS INFLIXIMAB, SUBCUTANEOUS INFLIXIMAB AND SUBCUTANEOUS ADALIMUMAB AS "TOP-DOWN" TREATMENT FROM DIAGNOSIS, ARE ALL MORE EFFECTIVE, SAFER AND LESS COSTLY THAN CONVENTIONAL 'STEP-UP' CARE FOR PATIENTS WITH ACTIVE CROHN'S DISEASE (UEGW 2025) - No abstract available

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Perceived benefits and cost savings of liquid formulation of intravenous infliximab: perspectives of seven European countries. (PubMed, Expert Opin Biol Ther) - "Following the approval of intravenous (IV) infliximab (IFX) in the 1990s, Celltrion developed the first monoclonal antibody biosimilar for IV IFX (Remsima®: Celltrion, South Korea), followed by the first and only subcutaneous IFX, (Remsima® SC). These savings allow resource reallocation to patient care, improving cost-effectiveness of IV IFX therapy. Its adoption is expected to optimize healthcare delivery across European healthcare systems."

HEOR • Journal

Comment on "Clinical, Radiological and Pharmacokinetic Data of CT‑P13 Subcutaneous in Individuals with Fistulizing Anoperineal Crohn's Disease". (PubMed, Dig Dis Sci) - No abstract available

Journal • PK/PD data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Switching from Intravenous to Subcutaneous Infliximab in Patients with Plaque Psoriasis (EADV 2025) - No abstract available

Clinical • Dermatology • Immunology • Psoriasis

Simulated Dosing Regimens of Subcutaneous Infliximab in Adults and Children with Inflammatory Bowel Disease: Exploring Switch and Initiation Strategies. (PubMed, Eur J Drug Metab Pharmacokinet) - "Infliximab exposure (AUC) remains largely similar when transitioning from standard IV to SC dosing. Current dosing regimens may not be optimal for patients with severe obesity, paediatric patients and patients on high-frequency infliximab regimens. These findings provide a foundation for future clinical research to refine SC infliximab dosing in these populations."

Journal • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Obesity • Pediatrics

Clinical, Radiological and Pharmacokinetic Data of CT-P13 Subcutaneous in Individuals with Fistulizing Anoperineal Crohn's Disease. (PubMed, Dig Dis Sci) - "CT-P13 SC appears to be at least as effective as the IV formulation for fistulizing anoperineal lesions, and switching from IV to SC allows remission to be maintained in the vast majority of cases. Despite numerically higher infliximab concentrations in patients in remission, no significant difference could be identified. Trial registration number and date: Registration with the ethics committee on 11/14/2023."

Journal • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Barriers, Drivers, and Outcomes in Transitioning Patients With Inflammatory Bowel Disease From Intravenous to Subcutaneous Infliximab. (PubMed, Crohns Colitis 360) - "Understanding patients' attitudes toward transition is essential to design a service that meets their needs. Services must be adequately resourced in order to ensure that patients treated with subcutaneous biologics continue to have ready access to high-quality care."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Celltrion's operating profit hits record high in Q2 on strong sales of new high-margin drugs (Korea Biomedical Review) - "The company said its second quarter revenue reached 961.5 billion won ($690.5 million), up 9.9 percent year-on-year, while operating profit jumped 234.5 percent to 242.5 billion won -- both all-time highs for the second quarter...The strong performance was driven by robust demand for Remsima SC (marketed as Zymfentra in the U.S.), a subcutaneous infliximab biosimilar for autoimmune diseases, Yuflyma, an adalimumab biosimilar for rheumatoid arthritis and inflammatory conditions, Vegzelma, a bevacizumab biosimilar used in cancer treatment, and Steqeyma, a ustekinumab biosimilar targeting psoriasis and Crohn’s disease."

Commercial • Breast Cancer • Crohn's disease • Glioblastoma • Immunology • Inflammatory Bowel Disease • Non Small Cell Lung Cancer • Ovarian Cancer • Psoriasis • Rheumatoid Arthritis

Immunogenicity with subcutaneous infliximab: the devil is in the details. (PubMed, Clin Gastroenterol Hepatol) - No abstract available

Journal

Immunogenicity and efficacy of subcutaneous infliximab monotherapy versus combination therapy in IBD. (PubMed, Clin Gastroenterol Hepatol) - No abstract available

Journal • Monotherapy • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Patient perspectives of switch in route of administration among patients established on long term intravenous infliximab therapy (BSG 2025) - "This study investigates patient preferences, willingness to switch from IV to SC, and factors associated with acceptability of switch.Methods We administered a 6-item questionnaire ranked on Likert's scale to patients undergoing planned switch from IV to SC Infliximab at our IBD centre...Mean acceptability score post SC switch (9.5, range 8-10) was better than prior to switch (8, range 5-10) with 86/88 (97.7%) patients reporting equal or higher scores post switch.Download figure Open in new tab Download powerpoint Abstract P267 Figure 1 Download figure Open in new tab Download powerpoint Abstract P267 Figure 2 Conclusion Patients with IBD tend to be more likely to choose SC administration than IV infusion, but preferences and drivers of choice may vary according among individuals. These findings may assist discussions around appropriate treatment choices for each patient."

Clinical • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Cost-effectiveness analysis of anti-TNF treatment from diagnosis for patients with moderate-severe crohn's disease: an analysis from the PROFILE trial (BSG 2025) - "Similar clinical benefits were obtained when modelling use of subcutaneous infliximab and adalimumab from diagnosis. Patients experience longer periods in remission, fewer disease-related flares, and enhanced quality of life. In newly-diagnosed patients with moderate and severe Crohn's disease, 'top-down' treatment with anti-TNF therapy is more efficacious, safer and cost-effective than an 'accelerated step-up' treatment strategy."

Clinical • Cost effectiveness • HEOR • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

Switching from intravenous to subcutaneous infliximab enhances trough levels and can facilitate de-escalation of concomitant immunomodulation, irrespective of HLA-DQA1*05 status (BSG 2025) - "It is feasible to de-escalate concomitant IMMs in a considerable proportion of patients following switch. Economic analysis of switch should be incorporated in the feasibility of IMMs withdrawal."

Immunomodulating • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • HLA-DQA1

Meta-Analysis: Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease. (PubMed, Aliment Pharmacol Ther) - "Subcutaneous infliximab is associated with high efficacy rates in IBD. Subcutaneous infliximab may offer clinical benefit above the intravenous formulation. This should provide patients and clinicians with confidence in using subcutaneous infliximab in IBD. Further head-to-head trials are needed to confirm the relative efficacy between these formulations."

Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Author's Reply to: "Immunogenicity with subcutaneous infliximab: the devil is in the details". (PubMed, Clin Gastroenterol Hepatol) - No abstract available

Journal

Comment on "Switching to Subcutaneous Infliximab Maintenance Therapy is Effective in Patients with Inflammatory Bowel Disease". (PubMed, Dig Dis Sci) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

A real-world comparison of subcutaneous to intravenous administration of infliximab in patients with inflammatory bowel disease. (PubMed, Intest Res) - "We compared intravenous and subcutaneous infliximab (IFX) as treatment for inflammatory bowel disease (IBD)...Analyzing the sequential changes compared with baseline data within each group, we observed significant alterations in subcutaneous; 6 months fecal calprotectin (676.3 ± 976.6 μg/g vs. 253.9 ± 483.9 μg/g, P= 0.014), 6 months IFX trough level (7.00 ± 5.67 μg/mL vs. 18.44 ± 6.34 μg/mL, P= 0.026), and 12 months IFX trough level (7.00 ± 5.67 μg/mL vs. 21.33 ± 4.50 μg/mL, P= 0.034). This study indicates the potential suitability of subcutaneous IFX as an alternative treatment option for IBD."

Journal • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Bringing IBD treatment options to the table. The latest developments in the Celltrion Healthcare IBD portfolio. (BSG 2025) - "Adverse events should also be reported to Celltrion Healthcare by emailing UKadverseevents@celltrionhc.com or calling +44 (0) 1753 983 500 For full indications, contraindications and information on special warnings, precautions and adverse events, please refer to the Summary of Product Characteristics. Please click here to view the Remsima® (infliximab) IV prescribing information: Please click here to view the Remsima® (infliximab) SC prescribing information: Please click here to view the Yuflyma®▼(adalimumab) prescribing information: Please click here to view the SteQeyma® (ustekinumab) prescribing information: UK--25-00086 May 2025"

Gastroenterology • Inflammatory Bowel Disease

Introducing the Celltrion IBD portfolio including SteQeyma®▼(ustekinumab) and Remsima® (infliximab) SC data (BSG 2025) - "Sponsored by Celltrion Healthcare UK Ltd"

Inflammatory Bowel Disease