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

…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

Drug-induced headache reports: a comprehensive disproportionality and time-to-onset pharmacovigilance study using the FAERS database (2018-2024). (PubMed, Front Pain Res (Lausanne)) - "The drugs with the highest headache risk based on ROR included glecaprevir/pibrentasvir (ROR = 10.445), sofosbuvir/velpatasvir (ROR = 9.729), and eptinezumab-jjmr (ROR = 6.775). Top frequently reported drugs were apremilast, treprostinil, and adalimumab...Early-onset headaches (≤7days) were particularly associated with ofatumumab and fingolimod. Late-onset headaches (>90days) were linked to treprostinil and infliximab-dyyb. This large-scale pharmacovigilance study identifies multiple drugs and therapeutic classes with significant associations to headache as an ADR. These findings highlight the need for proactive headache monitoring, particularly during early treatment phases, and warrant further prospective investigations to understand mechanisms and preventive strategies."

Adverse events • Journal • Pain

Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study. (PubMed, Clin Gastroenterol Hepatol) - "Although ileal disease is often more treatment-resistant, IFX SC maintenance therapy was effective versus PBO regardless of disease location, demonstrating consistent efficacy across segments including the terminal ileum."

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

Celltrion, Inc. today announced that the European Commission (EC) has granted marketing authorization for Remsima IV (intravenous) liquid formulation, the world’s first liquid formulation of IV infliximab. (Yahoo Finance) - "The approval is based on the comparability data between infliximab powder formulation and the liquid formulation; The new liquid formulation of infliximab, available in 100 mg and a newly introduced 350 mg presentation....The Remsima IV liquid formulation is approved in the EU for all indications of IV infliximab, matching the approved uses of all existing IV infliximab powder formulations, including rheumatoid arthritis (RA), adult and pediatric Crohn’s disease (CD), ulcerative colitis (UC), pediatric UC, ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO)."

EMA approval • Ankylosing Spondylitis • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Biosimilar switching in IBD: safety, efficacy, and immunogenicity in 10,812 patients - A systematic review and meta-analysis. (PubMed, Rev Esp Enferm Dig) - "Biosimilars maintain comparable efficacy, safety, and immunogenicity to originators in IBD, supporting their use in single or multiple switching scenarios. Standardized reporting of mucosal healing, drug monitoring, and economic metrics is critical to optimize biosimilar adoption in real-world practice."

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

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

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

Adherence to STRIDE-II Treat-to-Target Guidelines in Recent FDA-Approved IBD Drug Trials: A Comparative Review (ACG 2025) - "It remains unclear to what extent pivotal trials leading to these approvals adhered to STRIDE-II targets. A structured review was conducted of Phase 3 clinical trials that supported FDA approval of the following agents between 2021 and 2025: mirikizumab (Omvoh), guselkumab (Tremfya), upadacitinib (Rinvoq), etrasimod (Velsipity), infliximab-dyyb (Zymfentra), and subcutaneous vedolizumab (Entyvio SC). All six trials included clinical remission and endoscopic healing as primary or co-primary endpoints, consistent with STRIDE-II recommendations. However, none of the pivotal trials included biomarker normalization or validated QoL instruments as formal endpoints. Mirikizumab's LUCENT trials uniquely evaluated bowel urgency as a patient-reported symptom, a symptomatic target identified in STRIDE-II."

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

Aseptic Abscess Syndrome Causing Repeat Liver Abscess in a Patient With Ulcerative Colitis (ACG 2025) - "The abscess was drained, and she completed 3 weeks of ciprofloxacin and metronidazole for antimicrobial therapy...She was initially started on Piperacillin-Tazobactam and metronidazole for coverage of an intra-abdominal abscess, however these were discontinued following negative cultures. She re-started her infliximab-dyyb therapy with no abscess recurrence at 3 months...Abscesses can occur in a variety of organs including the spleen, skin, liver, lymph nodes, and lungs. Because many patients with IBD are on immunosuppression, each abscess should be considered infectious until proven otherwise.Figure: Loculated fluid collection measuring 5.2x2.4x6.3 cmFigure: Loculated fluid collection measuring 5.2x2.4x6.3 cm"

Clinical • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

A Snapshot of Subcutaneous Infliximab Use in Inflammatory Rheumatic Diseases: A Multicenter Italian Study (ACR Convergence 2025) - "Background/Purpose: A new subcutaneous formulation of infliximab (CT-P13) has recently become available for the treatment of inflammatory rheumatic diseases (IRDs), psoriasis and inflammatory bowel diseases. The study results suggest that scIFX provides sustained effectiveness over time for the treatment of IRDs. While factors such as line of treatment or BMI class do not affect DRR, the use of an induction dose appears to predict better treatment persistence."

Clinical • Ankylosing Spondylitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rare Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Vasculitis

…The most prescribed…therapy in Japan (Pulse by Maeil Business News Korea) - "In autoimmune disease treatments, Remsima (infliximab) holds 43 percent, and Yuflyma (adalimumab) commands 14 percent, ranking first among biosimilars in their respective categories."

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

Effectiveness of an Infliximab Biosimilar vs. Originator in Inflammatory Bowel Diseases: A Noninferiority Nationwide Study From the epi-IIRN. (PubMed, J Clin Gastroenterol) - "This study demonstrated noninferiority of infliximab biosimilar CT-P13 in comparison to the original in long-term management of IBD."

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

Post-Tonsillectomy Bleeding in a Patient with Crohn's Disease: Evaluating the Role of Coagulation Testing (AAO-HNSF 2025) - "Biologic therapy, infliximab-dyyb, for Crohn's was held 1 month prior to surgery. Crohn's disease can impact hemostasis. Existing guidelines for the perioperative management of patients with IBD do not specify the routine checking of coagulation profiles. Given the potential for bleeding events and the feasibility of testing, checking coagulation profiles in collaboration with primary care, hematology, or gastroenterology should be considered in this patient population."

Clinical • Crohn's disease • Gastroenterology • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Otorhinolaryngology

Efficacy and Safety of CT-P13/Infliximab-dyyb Biosimilar in Treatment of Nail Psoriasis and Psoriatic Arthritis (EADV 2025) - "Moreover, the availability of CT-P13 in a subcutaneous formulation (CT- P13 SC) has the added benefit to both improve patient convenience, compliance and reduce the burden on the healthcare system. CT-P13/infliximab-dyyb biosimilar is found to be efficacious and relatively safe in psoriasis of nails in our population, improving patient compliance, reducing burden on healthcare system as well reduced overall cost of therapy."

Clinical • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Obesity • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy and safety of biosimilars in gastroenterology: a focus on inflammatory bowel disease management. (PubMed, Expert Opin Biol Ther) - "The introduction of biosimilars changed the management of biologicals in inflammatory bowel disease (IBD) since the approval of CT-P13, the first biosimilar to infliximab, by the European Medicines Agency (EMA) in September 2013 and by the U.S. Food and Drug Administration (FDA) in April 2016...Clinical trials with biosimilars in IBD and evidence from real world studies on infliximab and adalimumab biosimilars confirm that safety, efficacy and immunogenicity is comparable to the originator, and that switching from the originator or among biosimilars is safe. While payers are supporting mandatory biosimilar use, on the long run the price race can lead to obstacles and unaffordability of the development of new originator biological agents."

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