Avsola (infliximab-axxq) / Amgen - 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

Primary Rectal Melanoma in a Patient With Ulcerative Colitis on Infliximab-axxq (ACG 2026) - "C) High Power H&E stain with melanophages (brown) and scattered mitotic figures. D) HMB45 Stain with positive result indicated by darkened areas"

Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Cutaneous Melanoma • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Leukemia • Melanoma • Mucosal Melanoma • Psoriasis • Skin Cancer • Solid Tumor • Ulcerative Colitis • BRAF • KIT • SOX10

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

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

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

Assessing the Value of Biosimilars: A Cost-Effectiveness Approach for Managed Care Organizations. (PubMed, J Pharm Pract) - "Biologics included Humira, Remicade, and Lantus, with biosimilars Cyltezo, Avsola, and Semglee. Pharmacists can help lead biosimilar use through counseling and substitution protocols. Greater alignment between clinical evidence and formulary practices can lower costs, improve access, and promote sustainable care."

HEOR • Journal • Crohn's disease • Diabetes • Gastroenterology • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology • Type 1 Diabetes Mellitus

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

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

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

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

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

Comparison of Reference and Biosimilar Medications for Pediatric Noninfectious Uveitis. (PubMed, Int Ophthalmol Clin) - "The most common reason for biosimilar initiation was insurance mandate. Compared with the reference infliximab, pediatric patients had fewer number of flares per year on biosimilar infliximab, but they were also on the biosimilar for a shorter duration of time compared with the reference which may confound an accurate assessment. Biosimilar infliximab had a lower cost profile compared with reference infliximab."

Clinical • Journal • Retrospective data • Inflammation • Ocular Inflammation • Ophthalmology • Pediatrics • Uveitis

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

Patterns of infliximab biosimilar uptake for Medicare, Medicaid, and private insurance from 2016-2022. (PubMed, Arthritis Rheumatol) - "Our results have two key findings for policy makers. First, our results suggest that 1 or 2 biosimilars may not generate enough competition to speed adoption rates for biosimilars. Second, Medicare, which covers most patients receiving biologics nationally, had slow adoption rates even after the third biosimilar was introduced. Policy levers to speed adoption among Medicare beneficiaries are needed."

Journal • Medicaid • Medicare • Reimbursement • US reimbursement • Rheumatology

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

Outcomes of the use of infliximab biosimilars in rheumatology and gastroenterology clinics. (PubMed, J Manag Care Spec Pharm) - "Clinical trials comparing infliximab biosimilars with the originator product have consistently demonstrated noninferiority, along with similar adverse effect profiles, leading to the approval of 3 additional biosimilars: Renflexis (infliximab-abda), Avsola (infliximab-axxq), and Inflectra (infliximab-dyyb). We conclude that the effort to convert clinically stable patients to a biosimilar product resulted in a significant increase in biosimilar use within the health system. This is thought to have resulted in significant financial advantages both to our institution as well as patients, without sacrificing overall clinical control."

Journal • Gastroenterology • Rheumatology

FDA Approves Infliximab Biosimilar for Subcutaneous Use Another infliximab biosimilar has been FDA approved, but this new version of Inflectra can be given subcutaneously for patients with inflammatory bowel disease. https://bit.ly/471jafo https://bit.ly/49pxZty

Regulatory

Comparing Uptake of Biosimilar Infliximab Among Patients with Medicare, Medicaid and Private Insurance in U.S. Rheumatology Practices 2016-2022 (ACR Convergence 2023) - "Background/Purpose: The first infliximab biosimilar (infliximab-dybb) entered the U.S. market in 2016, and two additional products have subsequently been introduced (infliximab-axxq (2017) and infliximab-abda (2020)). Adoption of biosimilar infliximab was quickest for Medicaid, with private insurance catching up after the release of a third biosimilar. Medicare uptake lagged significantly. To reduce drug spending, efforts are needed to understand poor Medicare uptake of biosimilars such as manufacturer rebates for biologics, and lack of financial incentives to switch to biosimilars."

Clinical • Medicaid • Medicare • Reimbursement • US reimbursement • Rheumatology

Therapeutic Hemicolectomy for Intractable Hemorrhage in New-Onset Fistulizing Crohn’s Disease (ACG 2023) - "Intravenous methylprednisolone 60mg daily with an infliximab-axxq loading regimen was ineffective as the patient required transfusion of >20 units of blood products over the course of 2 weeks. Figure: Figure 1: Multiple oozing ulcers visualized in the descending colon Figure 2: Active bleeding visualized throughout the ascending colon Figure 3: Large clot present in the sigmoid colon. Figure 4: Normal appearing ileum with an iatrogenic petechia."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease

Expanded table: Some drugs for inflammatory bowel disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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