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

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

INFLIXIMAB AND ITS BIOSIMILARS FOR INFLAMMATORY BOWEL DISEASE: ANALYSIS OF MEDICARE PART D CLAIMS AND COSTS (CCCongress 2024) - "This analysis of the Medicare Part D database assesses trends in total drug claims and costs for infliximab and its biosimilars, specifically, infliximab-dyyb (FDA approved in 2016) and infliximab-abda (FDA approved in 2017). Our analysis revealed varied shifts in the utilization of infliximab across states following the introduction of biosimilars (Figure 1). At the national level, biosimilars exhibited increased utilization. In contrast, both the utilization and cost of infliximab continued to rise; however, the rate of increase decelerated (Table 1)."

Medicare • Reimbursement • US reimbursement • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

The Biosimilar Switch: IBD nurse's experience in Our Lady of Lourdes Hospital (ECCO-IBD 2024) - "Results 86 patients were switched from the originator to the biosimilar Flixabi...Conclusion Of the 86 patients who were switched 22 responded to the questionnaire. 21 patients were happy with their overall experience with how the switch was conducted."

Clinical • Inflammatory Bowel Disease

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

Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019. (PubMed, J Manag Care Spec Pharm) - "We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs."

Journal • Medicare • Reimbursement • US reimbursement

FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - P4 | N=148 | Enrolling by invitation | Sponsor: University Medical Center Groningen | Recruiting ➔ Enrolling by invitation | Trial completion date: Jun 2023 ➔ Mar 2025

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

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

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology (BioSpace) - "In Europe, IMRALDI is commercialized by Biogen along with BENEPALI (etanercept; SB4) and FLIXABI (infliximab; SB2). Samsung Bioepis' and Biogen's anti-TNF treatment products have helped nearly 256,0003 patients in Europe. Details of the Samsung Bioepis’ abstracts are as follows: A Randomised, Double-blind, Phase III Study Demonstrating Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis...Steven Feldman...Long-Term Real-World Data of SB5 (Adalimumab Biosimilar) Treatment in Patients with Moderate-to-Severe Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR))...Steven Feldman..."

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

REMODEL-CD: Precise Infliximab Exposure and Pharmacodynamic Control (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: Children's Hospital Medical Center, Cincinnati | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • CRP • IFNG