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

Pharmacokinetics and efficacy of subcutaneous infliximab 120 mg every 2 weeks: a post hoc comparison with intravenous dosing in a phase 1 study in patients with inflammatory bowel disease. (PubMed, Crohns Colitis 360) - P1 | "A phase 1 study of CT-P13 demonstrated pharmacokinetic non-inferiority of subcutaneous (SC) infliximab (IFX) to intravenous (IV) IFX in patients with inflammatory bowel disease. Efficacy and safety outcomes were comparable between subsets throughout. These data support a favorable pharmacokinetic profile of the approved standard dose of IFX SC."

Journal • P1 data • PK/PD data • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials. (PubMed, Inflamm Bowel Dis) - P3 | "Dose escalation of subcutaneous infliximab led to rapid response recovery in most patients with CD and UC. Early recovery was associated with favorable long-term outcomes."

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

Comparison of the risk of acute anterior uveitis flare between adalimumab and subcutaneous infliximab in patients with radiographic axial spondyloarthritis and prior acute anterior uveitis: a randomized controlled trial (EULAR 2026) - No abstract available

Clinical • Ankylosing Spondylitis • Immunology • Ocular Inflammation • Ophthalmology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis

Utilising Advanced Therapies in Inflammatory Bowel Disease: Real-World Experience from a UK Centre (ECCO-IBD 2026) - "Biologics and small-molecule medications included anti-TNFα (Adalimumab, Infliximab IV/SC, Golimumab), anti-integrin (Vedolizumab IV/SC), anti-IL12/23 (Ustekinumab), anti-IL23 (Risankizumab), JAK inhibitors (Tofacitinib, Upadacitinib, Filgotinib), and anti-IL23p19 (Mirikizumab)...The observed shift toward subcutaneous Infliximab and Vedolizumab is consistent with global trends that support self-administration and service efficiency...Conclusion Although there is a substantial variability between consultants, the adoption of biologics within this large NHS Trust is consistent with national and international prescribing trends. The results corroborate the need for multidisciplinary assessment and standardization of biologic initiation pathways in order to optimize equality and consistency in advanced IBD treatment."

Clinical • Metastases • Real-world • Real-world evidence • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

Letter to the editor: enhancing the robustness of early vs late switch to subcutaneous infliximab in inflammatory bowel disease (IBD): the value of propensity score analysis. (PubMed, Inflamm Bowel Dis) - No abstract available

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

Response to Letter to the Editor: "Enhancing the robustness of early vs late switch to subcutaneous infliximab in inflammatory bowel disease (IBD): the value of propensity score analysis". (PubMed, Inflamm Bowel Dis) - No abstract available

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

A Pilot Study of the Effectiveness and Safety of Subcutaneous Infliximab in Chronic Inflammatory Pouch Conditions: The St. Mark's Experience. (PubMed, J Clin Med) - " Switching clinically stable patients with chronic inflammatory pouch conditions from IV to SC IFX formulation appears feasible. These findings warrant confirmation in larger patient cohorts."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology

COMPARING HTA DECISIONS, PRICING NEGOTIATIONS, AND REIMBURSEMENT OF INFLIXIMAB BIOLOGIC ORIGINATOR AND BIOSIMILARS IN CANADA (ISPOR 2026) - "Five infliximab biosimilars were covered by all provincial/territorial drug plans, except Yukon, which only covered two biosimilars (Renflexis® and Remdantry™)...INESSS conducted HTAs for two additional biosimilars (Ixifi® and Avsola®), which both received a positive recommendation...Remicade® and all infliximab products, except for Remsima™ SC for the UC indication, concluded with a Letter of Intent in pCPA negotiations. Biosimilar market entry has provided patients with additional treatment options for indications that were not originally reimbursed by public drug plans for the originator. Policies supporting biosimilar use have allowed provinces and federal drug plans to expand access to biologic therapies for more patients within cost constraints."

Pricing • Reimbursement • US reimbursement • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Celltrion biosimilars gain share in Australia and New Zealand (Korea Biomedical Review) - "According to IQVIA, as of the third quarter of 2025, the biosimilar Herzuma (trastuzumab), used to treat breast and gastric cancers, held more than 56 percent of the market in Australia....In autoimmune disease treatments, Celltrion’s Remsima (infliximab) and Remsima SC (subcutaneous formulation) hold a combined market share of 58 percent in Australia....Steqeyma (ustekinumab) reached a 12 percent market share within its first quarter of sales, based on IQVIA data."

Commercial • Ankylosing Spondylitis • Crohn's disease • Gastric Cancer • HER2 Positive Breast Cancer • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Higher persistence with subcutaneous infliximab compared to vedolizumab in stable inflammatory bowel disease patients switching from maintenance intravenous therapy confirmed in an independent multicentre validation cohort. (BWG 2026) - "This multicentre validation cohort confirmed higher SC treatment persistence with infliximab compared to vedolizumab in stable IBD patients after switching from maintenance IV therapy. Discontinuation was mainly related to disease activity or adverse events, and was more frequent in women and vedolizumab users."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

BIRDIE: Subcutaneous infliximab in IBD patients previously treated with an optimized intravenous infliximab dosing schedule: Baseline characteristics linked to willingness to switch. (BWG 2026) - P4 | "Introduction: Subcutaneous (SC) infliximab (IFX) CT-P13 offers an alternative to intravenous (IV) administration, yet evidence remains limited regarding its use in patients maintained on optimized IV dosing (1). Apart from younger age being associated with greater willingness to switch, baseline characteristics did not differ between willing or unwilling to switch from optimized IV to SC IFX. Motivations for switching were mainly practical, reflecting a desire in reduced hospital visits and time savings, while reluctance was primarily driven by fear of change and concerns about disease control. The AMARETTO trial will further clarify whether weekly SC dosing offers superior outcomes compared to bi- weekly SC IFX in this population."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

The Great Debate: When Is the Right Time to Switch to Infliximab SC? Early switch approach vs Remission-based approach. (BWG 2026) - "Sponsored by CELLTRION"

Clinical

Subcutaneous Infliximab and Assumptions of Response in Ileal Crohn's Disease: Does Route of Administration Matter? (PubMed, Clin Gastroenterol Hepatol) - No abstract available

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

Subcutaneous infliximab in inflammatory bowel disease: bridging the gap between theory and practice. (PubMed, Crohns Colitis 360) - "The adoption of SC IFX could profoundly change the therapeutic landscape, offering a more patient-centered approach to long-term disease control but some questions remain, particularly about the place of IFX in certain populations. In this article, we reviewed the known and unknown data on SC IFX to provide a comprehensive summary and assist IBD physicians in integrating this knowledge into everyday clinical practice."

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

LONG-TERM EFFECTIVENESS, SAFETY, ACCEPTABILITY, AND PROGRESSION OF BOWEL DAMAGE OF SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB IN PATIENTS WITH INFLAMMATORY BOWEL DISEASES TREATED WITH INTENSIFIED DOSES: THE REMSWITCH-VLT STUDY (DDW 2026) - No abstract available

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

RANDOMISED CONTROLLED TRIAL OF WITHDRAWAL OF THIOPURINES WHEN SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB: RESULTS OF THE MINIMISE STUDY (DDW 2026) - No abstract available

Clinical • Inflammatory Bowel Disease

RANDOMISED CONTROLLED TRIAL OF CONTINUED INTRAVENOUS VERSUS SWITCHING TO SUBCUTANEOUS INFLIXIMAB IN INFLAMMATORY BOWEL DISEASE: THE SUBCUTANEOUS INFLIXIMAB SWITCH STUDY (SISS). (DDW 2026) - No abstract available

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

COMPARISON OF EFFECTIVENESS BETWEEN SUBCUTANEOUS INFLIXIMAB AS MONOTHERAPY OR COMBINED WITH AN IMMUNOSUPPRESSANT IN PATIENTS WITH CROHN'S DISEASE: INTERIM RESULTS FROM THE REMONO-CD STUDY. (DDW 2026) - No abstract available

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

RECAPTURING DISEASE CONTROL WITH SUBCUTANEOUS INFLIXIMAB AFTER A DRUG HOLIDAY FOLLOWING INTRAVENOUS INFLIXIMAB INDUCTION: A POST HOC ANALYSIS OF LIBERTY-CD AND -UC STUDIES (DDW 2026) - No abstract available

Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Real-world Comparison of Subcutaneous versus Intravenous Infliximab in Patients with Active Inflammatory Bowel Disease (ECCO-IBD 2026) - "Conclusion In this multicenter real-world cohort, subcutaneous infliximab demonstrated pharmacokinetic advantages and similar rates of treatment persistence and efficacy compared to the intravenous formulation, with a lower need for concomitant immunosuppression and dose intensification. Patients showed a statistically significant preference for the IFX-SC route of administration."

Clinical • Real-world • Real-world evidence • Immunology • Inflammation • Inflammatory Bowel Disease

A Propensity Score Weighted Comparison of Intravenous and Subcutaneous Infliximab as Maintenance Treatment in Patients with Inflammatory Bowel Disease: the CISI Study (ECCO-IBD 2026) - "Conclusion Switching from IV IFX to SC CT-P13 demonstrated comparable persistence, safety, and disease control to continued IV therapy in IBD patients with stable remission. In the long term, the SC formulation may be associated with greater treatment persistence."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Effectiveness of Subcutaneous Infliximab in Patients with Perianal Fistulizing Crohn’s Disease (ECCO-IBD 2026) - "Radiologic fistula remission was observed in 28 patients (65.1%) at baseline pMRI and was maintained in 27 patients, while one patient experienced worsening of mVAI. Conclusion SC‑IFX maintained radiologic fistula remission and reducing mVAI in some baseline non‑remitters, supporting its real‑world effectiveness in pfCD."

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

Real-world experience of switching from intravenous to subcutaneous infliximab in pediatric Inflammatory Bowel Disease patients: a multicenter retrospective cohort from the Canary Islands, Spain. (ECCO-IBD 2026) - "IFX-SC appears to be a practical and well-tolerated alternative to intravenous therapy in PIBD, particularly in settings where logistical burden and treatment autonomy are relevant. Larger cohorts with longer follow-up are needed"

Real-world • Real-world evidence • Retrospective data • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Pharmacokinetic Predictor of Infection in Patients with Inflammatory Bowel Disease Treated with Intravenous and Subcutaneous Infliximab (ECCO-IBD 2026) - "A parsimonious mixed-effects model confirmed AUC0–8wk as the primary predictor. Conclusion Cumulative exposure, rather than Ctrough, predicts infection risk, supporting AUC monitoring for safer IFX dosing."

Clinical • PK/PD data • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

Serum concentrations of infliximab are comparable with and without immunosuppression during subcutaneous infliximab induction treatment for Crohn's disease (ECCO-IBD 2026) - "Patients were randomized to SC IFX mono- or combination therapy with an IMM (thiopurine or methotrexate). Carriers of HLA-DQ5 showed lower IFX exposure and higher immunogenicity. These data suggest limited added benefit of concomitant IMM for IFX pharmacokinetics during intensified SC IFX induction."

Crohn's disease • Immunology • Inflammatory Bowel Disease • HLA-DQA1