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

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

Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX-SIRIUS STUDY I (the IFX-SIRIUS STUDY II): A clinical, ultrasound, and biomarker-based effectiveness after discontinuation and reinitiation of biosimilar infliximab. (PubMed, Glob Health Med) - "Over 50% of the patients maintained non-clinical relapse after CT-P13 discontinuation, and relapsed patients improved after re-administration without adverse events. This study was registered in the Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp) on April 20, 2020, as jRCTs071200007."

Biomarker • Journal • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Diseases • Rheumatoid Arthritis • Rheumatology

Optimizing the switch from escalated intravenous to subcutaneous infliximab: a population pharmacokinetics-pharmacodynamics study. (PubMed, J Crohns Colitis) - "Patients on Q6W and Q8W IV regimens may switch to standard SC infliximab without an increase in FC."

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

The company announced on Aug. 28 that it has obtained sales approval for Remsima, an autoimmune disease treatment…in Vietnam, completing their launches in June…of this year (Business Korea)

Launch non-US • Immunology

Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): An interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments. (PubMed, Drug Discov Ther) - "Three non-serious adverse events occurred, with no study discontinuations due to adverse events. In conclusion, most RA patients undergoing treatment with originator IFX in clinical remission could safely switch to CT-P13 without an increased risk of relapse, as evidenced by MSUS, clinical indices, and biomarker levels."

Biomarker • Journal • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Oncology • Rheumatoid Arthritis • Rheumatology • CRP • TNFA

SIC2: Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease (clinicaltrials.gov) - P=N/A | N=22 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Active, not recruiting ➔ Completed

Trial completion • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT). (PubMed, Adv Ther) - P=N/A | "After 2 years of follow-up, the effectiveness of intravenous CT-P13 was maintained in > 65% of IFX-switched patients and CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile."

Journal • Observational data • Real-world evidence • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Celltrion expands footprint in Italy with continued wins for autoimmune…drugs (Korea Biomedical Review) - "Celltrion’s Italian subsidiary recently won additional tenders for its ustekinumab biosimilar, Steqeyma, in the Veneto, Trentino-Alto Adige, and Sardinia regions, following earlier contracts in four regions this year...The company will supply the drug to seven regions in total through May 2026...Remsima IV won a recent tender in Umbria, while Remsima SC renewed its contract in Puglia, extending supply through May 2027...Celltrion’s adalimumab biosimilar Yuflyma is also gaining traction, with sales underway in Lazio and Umbria under contracts that will run for the next two to three years."

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

Perceived benefits and cost savings of liquid formulation of intravenous infliximab: perspectives of seven European countries. (PubMed, Expert Opin Biol Ther) - "Following the approval of intravenous (IV) infliximab (IFX) in the 1990s, Celltrion developed the first monoclonal antibody biosimilar for IV IFX (Remsima®: Celltrion, South Korea), followed by the first and only subcutaneous IFX, (Remsima® SC). These savings allow resource reallocation to patient care, improving cost-effectiveness of IV IFX therapy. Its adoption is expected to optimize healthcare delivery across European healthcare systems."

HEOR • Journal

Immunogenicity and efficacy of subcutaneous infliximab monotherapy versus combination therapy in IBD. (PubMed, Clin Gastroenterol Hepatol) - No abstract available

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

Bringing IBD treatment options to the table. The latest developments in the Celltrion Healthcare IBD portfolio. (BSG 2025) - "Adverse events should also be reported to Celltrion Healthcare by emailing UKadverseevents@celltrionhc.com or calling +44 (0) 1753 983 500 For full indications, contraindications and information on special warnings, precautions and adverse events, please refer to the Summary of Product Characteristics. Please click here to view the Remsima® (infliximab) IV prescribing information: Please click here to view the Remsima® (infliximab) SC prescribing information: Please click here to view the Yuflyma®▼(adalimumab) prescribing information: Please click here to view the SteQeyma® (ustekinumab) prescribing information: UK--25-00086 May 2025"

Gastroenterology • Inflammatory Bowel Disease