Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon - LARVOL DELTA

Infliximab Biosimilars vs Originator Infliximab in Biologic-Naïve Ulcerative Colitis: Real-World 3-Year Outcomes From a Propensity Score-Matched Cohort (ACG 2026) - "The study population was categorized into two groups: those treated with infliximab biosimilarsâinfliximab-abda (Renflexisâ¢), infliximab-dyyb (Inflectraâ¢), or infliximab-axxq (Avsolaâ¢), and those treated with the originator infliximab (infliximab; Remicadeâ¢). Following 1:1 propensity score matching, 576 matched pairs (N = 1,152) were included in the final analysis. Notably, 10 (1.7%) of patients in the biosimilars group were identified as having insufficient insurance or social welfare support. Similarly, 10 (1.7%) of patients in the biosimilars group were identified with homelessness."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Adverse events • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms (clinicaltrials.gov) - P1/2 | N=8 | Recruiting | Sponsor: University of California, San Francisco | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Jun 2027 ➔ Jun 2028

Trial completion date • Trial primary completion date • Cardiovascular • Oncology • Vasculitis

2025.36: Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors (clinicaltrialsregister.eu) - P4 | N=202 | Not yet recruiting | Sponsor: Sint Maartenskliniek Stichting

Head-to-Head • New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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

RENFLEXIS-ASSOCIATED PAUCI-IMMUNE CRESCENTIC GLOMERULONEPHRITIS: A RARE CAUSE OF RAPIDLY PROGRESSIVE KIDNEY FAILURE (WRMC 2026) - "The patient was started on pulse dose corticosteroids followed by weight based taper per the PEXIVAS trial, as well as renally dosed IV cyclophosphamide (7.5 mg/kg every two weeks). To our knowledge, pauci-immune RPGN associated with infliximab-abda has been infrequently reported, especially in the setting of long term stability on infliximab prior to switching to infliximab-abda. This case underscores the importance of vigilance for renal toxicity in patients receiving TNF-α inhibitors and their biosimilars, as prompt recognition and aggressive immunosuppression are critical for preservation of renal function."

Acute Kidney Injury • Chronic Kidney Disease • Dermatology • Fibrosis • Glomerulonephritis • Gout • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus Nephritis • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Orthopedics • Psoriasis • Renal Disease • Rheumatology

PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Melanoma • Oncology • Solid Tumor • LAG3

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Melanoma • Oncology • Skin Cancer • Solid Tumor • PD-L1

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Therakos LLC | N=30 ➔ 0 | Suspended ➔ Withdrawn

Checkpoint inhibition • Enrollment change • Trial withdrawal • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jun 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Adverse events • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Expanding the clinical utility of reporter gene assay to infliximab biosimilars. (PubMed, Clin Chim Acta) - "A functional cell-based reporter gene assay was validated for measuring serum concentrations of infliximab biosimilars and neutralizing antibodies. This study supports the bio- equivalency and cross-immunogenicity of parent drug and biosimilars and offers guidance for management of patients switching therapies between parent drug and biosimilars."

Journal • Inflammation

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) - P2 | N=30 | Suspended | Sponsor: Therakos LLC | Initiation date: Jan 2025 ➔ Dec 2025 | Not yet recruiting ➔ Suspended

Checkpoint inhibition • Trial initiation date • Trial suspension • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2024 (GlobeNewswire) - "Biosimilars revenue increased 12% on both an as-reported and ex-FX basis for full year 2024, compared with the prior year, primarily driven by growth in Hadlima, following its U.S. launch in July 2023. Renflexis and Ontruzant declined 1% ex-FX and 9% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure. Established Brands revenue grew 2% both on an as-reported basis and ex-FX in the fourth quarter of 2024, primarily related to the revenue contribution of Emgality (galcanezumab-gnlm) and Vtama (tapinarof), which together more than offset the impact of the loss of exclusivity ('LOE') of Atozet (ezetimibe and atorvastatin) in key markets in Europe and in Japan."

Commercial • Ankylosing Spondylitis • Atherosclerosis • Atopic Dermatitis • Breast Cancer • Crohn's disease • Dyslipidemia • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

ASSOCIATED COST DIFFERENCES OF SWITCHING BETWEEN INFLIXIMAB PRODUCTS (CCCongress 2025) - "Ninety-two percent (n=1,642) of all first-time switches were from the infliximab originator to a biosimilar, with 72% (n=1,286) switching to infliximab-dyyb, 13% (n = 227) to infliximab-abda and 7% (n=129) to infliximab-axxq. The prevalence of switching to an infliximab biosimilar increased throughout the study period with more than half of infliximab product switches occurring in 2021. Cost savings following a switch was most significant in 2019. This study did not demonstrate any savings for patients when switching infliximab products."

Pediatrics

FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - P4 | N=148 | Enrolling by invitation | Sponsor: University Medical Center Groningen | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of Nonmedical Switches From Reference Infliximab to Biosimilars on Disease Control Within a Rheumatology Practice. (PubMed, J Pharm Technol) - " This retrospective analysis of data was conducted on all adult patients at our institution's rheumatology clinics with a rheumatologic diagnosis who were stable on reference infliximab and switched to the formulary biosimilars infliximab-dyyb or infliximab-abda, during the study period. Two of these eight patients (25%) had a delay in treatment after the switch, which may be a risk factor for flaring/loss of disease control. Pharmacists should be following patients who switch to biosimilar closely during the transition period, to monitor for signs of flares/loss of disease control."

Journal • Hematological Disorders • Oncology • Rheumatology • TNFA

Infliximab Biosimilars in Pediatric Inflammatory Bowel Disease: Comparison and Adverse Effects (AIBD 2024) - " A retrospective chart review was conducted on the potential acute AEs experienced by patients receiving either infliximab infusions or 1 of 3 infliximab biosimilar infusions: infliximab-dyyb, infliximab-abda, or infliximab-axxq...All patients were premedicated with acetaminophen and diphenhydramine... Infusions of infliximab biosimilars were not associated with an increase of acute infusion reactions compared with infliximab infusions indicating that biosimilar infusions are well-tolerated and safe to use for treatment of IBD in pediatric patients. No adverse events were noted when interchanging between Infliximab and Infliximab Biosimilar."

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

Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study. (PubMed, Therap Adv Gastroenterol) - "Reverse switching had no impact on efficacy of infliximab therapy in our cohort of IBD patients. The switch didn't influence immunogenicity or safety of therapy."

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

A Survey Among IBD Patients Following Switching From Originator Infliximab to Its Biosimilars (ACG 2024) - "Since 2016, the FDA has approved three IFX biosimilar agents (SB2), Renflexis®, Avsola™, and Inflectra®. Sixty-seven eligible patients (12 UC and 55 CD) were enrolled in the study, with 41 patients completing the survey. For question 1 (Q1), 84.6% of respondents answered "very satisfied," indicating that their providers did an excellent job counseling them on SB2. Regarding symptom control (Q2) and overall experience with SB2 (Q3), 82% and 85.4% of patients, respectively, rated their satisfaction as "Satisfied" or above."

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

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Therakos, LLC, a Mallinckrodt Company

Checkpoint inhibition • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Real-world experience with biosimilar infliximab-adba and infliximab-dyyb among infliximab-naïve patients with inflammatory bowel disease in the Veterans Health Administration. (PubMed, Medicine (Baltimore)) - "In September 2018, biosimilar IFX-abda (Renflexis) became the VANF IFX product. IFX utilization and laboratory patterns were clinically similar among the IFX biosimilars and RP groups, suggesting that providers did not modify their practice with biosimilars. Statistically significant differences in IFX utilization patterns are explained by formulary dynamics when the VANF product switched from IFX-dyyb to IFX-abda."

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

Inpatient Infliximab Biosimilar Cost-Savings - Cost analysis of inpatient treatment with originator Infliximab (Remicade™) vs biosimilar Infliximab (Renflexis™) for acute severe ulcerative colitis. . (PubMed, Dig Dis) - "Our calculation included median decision support drug cost as a percentage of the total inpatient cost of care, controlling for infliximab dose and length of stay. This reduced cost structure promotes use of Renflexis for ASUC inpatients and may reduce costs for patients and hospitals."

Cost-analysis • HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Pembrolizumab + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2023 ➔ Jun 2025

Adverse events • Combination therapy • Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jun 2023 ➔ Jun 2030 | Trial primary completion date: Jun 2023 ➔ Jun 2030

Checkpoint inhibition • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Melanoma • Oncology • Skin Cancer • Solid Tumor • PD-1 • PD-L1

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P4 | N=900 | Recruiting | Sponsor: Connecticut Children's Medical Center | Phase classification: P ➔ P4

Phase classification • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology