Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer - 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

Exhibitor Product Theater - Evolving Infliximab Maintenance: Insights from Emerging Post-hoc and Real-World Evidence of ZYMFENTRA� (infliximab-dyyb) (ACG 2026) - "These programs are independent of the ACG 2026 Annual Scientific Meeting and Postgraduate Course programs. No CME is provided for Exhibitor Product Theater presentations."

Clinical • HEOR • Real-world • Real-world evidence • Retrospective data

Biologic drugs for induction and maintenance of remission in Crohn's disease: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "This review has supported evidence generation, but head-to-head comparative trials for key interventional subclasses or specific agents may be needed, as guided by key stakeholders; for example, on the use of biosimilar versions of medications out of patent. The role of concomitant purine analogues is a key confounding factor and future studies may not only want to investigate specifically the role of combinations, but also consider stratifying populations or purposefully excluding participants based on this key class of therapy to avoid such heterogeneity. Given the majority of evidence focusses on the outcomes of clinical remission and relapse, future studies may want to further consider other outcomes of clear interest to clinicians and patients, particularly endoscopic remission. Finally, long-term safety data are limited throughout the networks. Whilst future studies with longer follow-ups could provide increased data, it may be that study designs outside of..."

Clinical • Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL7R

Celltrion’s infliximab biosimilar Remsima has become the most prescribed infliximab product in Japan, 11 years after entering a market where biosimilars have traditionally faced limited price-driven incentives (Korea IT Times) - "According to Celltrion, Remsima captured a 48% share of Japan’s infliximab market in July, based on data from pharmaceutical market research firm IQVIA and local sources. The milestone marks the first time since its Japanese launch in 2015 that Remsima has taken the top position in the market....Celltrion is preparing to launch Remsima SC in Japan in 2027."

Commercial • Launch Japan • Ankylosing Spondylitis • Crohn's disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting. (PubMed, Clin Pharmacol Ther) - "The product distribution also differed, with adalimumab-aacf most common in suffix-only reports (18.9%) vs. infliximab-dyyb overall (21.1%). Manufacturer information was present in 42.6% of suffix-only reports. These results suggest FDA's nonproprietary naming convention has achieved limited implementation for biosimilars in AEMS reporting practices, and other information present in AEMS reports may be sufficient for accurately identifying biosimilar products."

Adverse events • Journal • P4 data

Nationwide Trends and Cost Implications of Switching Between Infliximab Products. (PubMed, Am J Manag Care) - "Switching to infliximab biosimilars increased over the study period. Cost savings for insurers peaked in 2019 but were negligible by 2021. Patients did not experience any savings from switching. Because nonmedical switching burdens providers and risks patient harm without clear economic benefits, mandatory switches demand greater system transparency to prioritize patient welfare."

Journal • Retrospective data

Celltrion said its autoimmune disease treatments Remsima, Yuflyma, and Steqeyma won a national tender in Portugal. (Chosun Biz)

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

Immunomodulators and advanced therapies for maintenance of remission in Crohn's disease: systematic review and network meta-analysis. (PubMed, Ther Adv Gastroenterol) - "Upadacitinib is more effective than placebo at preventing loss of clinical response (RR 0.64, 95% CI 0.57-0.72, NNT = 2, small magnitude), while CT-P13 (RR 0.46, 95% CI 0.35-0.53, NNT = 1, large magnitude), natalizumab (RR 0.54, 95% CI 0.43-0.68, NNT = 2, moderate magnitude), certolizumab (RR 0.57, 95% CI 0.47-0.7), NNT = 2, moderate magnitude), adalimumab (RR 0.68, 95% CI 0.61-0.75, NNT = 2, small effect magnitude) and ustekinumab (RR 0.73, 95% CI 0.61-0.86, NNT = 2, small magnitude) probably prevent loss of clinical response. Infliximab (RR 0.7, 95% CI 0.59-0.82) and vedolizumab (RR 0.82, 95% CI 0.68-0.99) may prevent loss of clinical response...Novel therapies seem to have similar effect sizes, though imprecision due to limited evidence precludes further conclusions. https://knowledge.lancashire.ac.uk/id/eprint/53237/."

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

Association of Body Mass Index with SARS-CoV-2 Infection in Inflammatory Arthritis Patients Receiving Biologic Therapy: Singapore National Biologics Register Findings. (PubMed, Int J Rheum Dis) - "Being overweight or obese (BMI ≥ 23 kg/m2) was independently associated with higher COVID-19 infection risk. Severe infections were rare."

Journal • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Obesity • Oncology • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Multiple switches between infliximab originator and biosimilars in pediatric inflammatory bowel disease. (PubMed, J Pediatr Gastroenterol Nutr) - "Switching to CT-P13 biosimilars appears to maintain remission without relevant changes in pharmacokinetics, disease activity, or adverse events in pediatric patients with IBD. Further studies are required."

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

The autoimmune disease treatments Inflectra and Steqeyma recorded 30.5% and 10.2% market shares, respectively, in the United States (Chosun Biz)

Commercial • Ankylosing Spondylitis • Crohn's disease • Giant Cell Arteritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Reply to: 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

A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps (clinicaltrials.gov) - P=N/A | N=881 | Active, not recruiting | Sponsor: Celltrion | Recruiting ➔ Active, not recruiting

Enrollment closed • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

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

…Celltrion's autoimmune disease therapies are also expanding their share in Japan (Chosun Biz) - "The infliximab biosimilar 'Remsima' holds a 43% share in Japan, while the adalimumab biosimilar 'Yuflyma' holds 17%....Celltrion...plans to launch the tocilizumab biosimilar 'Avtozma' in the second quarter of this year."

Biosimilar launch • Commercial • Ankylosing Spondylitis • Crohn's disease • Giant Cell Arteritis • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

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

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

Willingness to switch from optimized intravenous to subcutaneous infliximab in IBD: baseline characteristics from the AMARETTO trial. (ECCO-IBD 2026) - P4 | "Background Subcutaneous (SC) infliximab (IFX) CT-P13 offers an alternative to intravenous (IV) administration, but evidence in patients maintained on optimized IV dosing remains limited (1). Motivations for switching were mainly practical, reflecting a desire to reduce hospital visits and save time, 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."

Inflammatory Bowel Disease

Subcutaneous infliximab (CT-P13) in Inflammatory Bowel Disease: Real-World Effectiveness and Safety. Observational retrospective single tertiary centre study. (ECCO-IBD 2026) - "Conclusion Subcutaneous IFX (CT-P13) appears to be an effective and well-tolerated therapeutic option for patients with Crohn’s disease in clinical practice. The observed increase in serum IFX concentrations is consistent with previous publications."

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

Determination of correlation of clearance with clinical outcomes for inflammatory bowel disease. (PubMed, World J Gastroenterol) - "Initial IFX clearance correlates with efficacy metrics and ADA formation. These probability curves may be useful to identify patients at risk of treatment failure or ADA who may benefit from individualized therapy. iDose-guided treatment successfully achieved targeted serum IFX concentrations, reducing risk of ADA formation. Proactive therapeutic drug monitoring and targeted dosing based on early IFX clearance may improve treatment outcomes for patients with IBD."

Biomarker • Clinical • Clinical data • Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CRP

Product Theater: Understanding Zymfentra(infliximab-dyyb) (Celltrion Usa, Inc) (CCCongress 2026) - "Supported by: Celltrion USA, Inc Please join us for this product theater with Dr. Christian Stone highlighting the key clinical characteristics of Zymfentra(infliximab-dyyb)"

Lung microbial dysregulation and TNF inhibition contribute to worsened nontuberculous mycobacterial lung disease. (PubMed, Res Sq) - "Young (4-6 years old) rhesus macaques were pretreated with nebulized amikacin and vancomycin to deplete the lung microbiome, pretreated with the TNF inhibitor Inflectra or left untreated. No control animals showed granulomas. These data suggest that lung microbiome dysbiosis and TNF inhibition can increase susceptibility to NTM granulomatous disease."

Journal • Immunology • Nontuberculous Mycobacterial Disease • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases

Outcomes of an Intravenous to Subcutaneous Infliximab (CT-P13) Strategy in Takayasu Arteritis: A Proof-of-Concept Prospective Study. (PubMed, ACR Open Rheumatol) - "IV-IFX to SC-IFX switching was feasible and well tolerated and generally maintained remission over 12 months in most patients with TA, with stable metabolic imaging and no increase in damage accrual. These findings support SC-IFX as a practical maintenance strategy, warranting confirmation in larger multicenter cohorts."

Journal • Vasculitis • CRP

ZEST: Zymfentra (Infliximab-dyyb) REal World Cohort STudy (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Not yet recruiting ➔ Recruiting

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

Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease. (PubMed, Intest Res) - "The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values."

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