Ixifi (infliximab-qbtx) / Pfizer, Sandoz - LARVOL DELTA

Pfizer’s IXIFI will be available in Canada as of April 1, 2025 (Canada Newswire) - "Pfizer Canada is pleased to announce that IXIFI (infliximab for injection) will be available in Canada as of April 1....It was approved by Health Canada in December 2021 for all eligible indications of the reference product, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (in adults and pediatric patients 9 years and older), fistulising Crohn's disease, ulcerative colitis (in adults and pediatric patients 6 years and older), psoriatic arthritis, and plaque psoriasis."

Biosimilar launch • Ankylosing Spondylitis • Crohn's disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Is mutiple switching between infliximab biosimilars safe in iInflammatory Bowel Disease? (ECCO-IBD 2025) - "In Turkey, three commercial IFX preparations are available, one of which is the original product: REMICADE® (Janssen Biotech, Inc., Horsham, PA, USA), REMSIMA™ (Celltron, Inc., Incheon, Korea), and IXIFI® (Pfizer, USA)...Our results are consistent with the studies in literature(3,4) . However, long-term effects of switching between biosimilars and original products should be evaluated in more comprehensive studies."

Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and safety of infliximab biosimilars in the treatment of patients with moderate-to-severe psoriasis (PsoriasisG2C 2024) - "We report our experience regarding the efficacy and safety of the infliximab biosimilar agents (Inflectra, Zessly, Remsima) in treating patients with moderate-to-severe psoriasis...Fifteen (19%), 22 (28%), 13 (16%), and 78 (99%) patients had failed after cyclosporine, methotrexate, acitretin, and other biologic systemic therapies, respectively...According to our study, the infliximab biosimilars demonstrated a favourable efficacy and safety profile. The data 63 provided by our experience contribute to the evidence needed for the clinical evaluation and appropriate incorporation of infliximab biosimilars in the standard treatment of patients with moderate-to-severe psoriasis."

Clinical • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Infliximab biosimilar GP1111: a review of 5 years' post-approval experience. (PubMed, Expert Opin Biol Ther) - "Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe...Results from the Phase III REFLECTIONS trial in patients with moderate-to-severe active RA despite methotrexate therapy confirmed the similarity in efficacy and safety between GP1111 and reference infliximab...In addition, budget impact analysis of various sequential targeted treatments in patients with RA found that GP1111 was cost-effective when used early after failure of conventional synthetic disease-modifying antirheumatic drugs. Therefore, 5 years' post-approval experience with GP1111 in RA and IBD, and key clinical and real-world evidence, support the safety and efficacy of continued use of GP1111 in all infliximab-approved indications."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Rheumatoid Arthritis • Rheumatology • Ulcerative Colitis • TNFA

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. (PubMed, Expert Opin Biol Ther) - "Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment. Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%). The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval."

Journal

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch. (PubMed, Drug Saf) - "This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity."

Biosimilar launch • Journal • Real-world • Real-world evidence

Cost-Utility and Budget Impact Analyses of Tumor Necrosis Factor Inhibitor Biologics and Biosimilars Versus Rituximab in Thai Patients with Active Rheumatoid Arthritis (ISPOR-EU 2023) - "We compare the effectiveness of six TNFi (etanercept, infliximab, golimumab, two infliximab biosimilars; Remsima® and Ixifi®, and an adalimumab biosimilar: Amgevita®) with rituximab or its biosimilar, Truxima®. For RA patients with high disease activity eligible to a biologic DMARDs in Thailand, adalimumab biosimilar should be considered the first option over rituximab, regarding the potential budget savings and enhanced patient outcomes."

Clinical • HEOR • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Switching from SB2 to PF-06438179/GP1111 and back in inflammatory bowel disease: "The Superswitchers". (PubMed, Dig Liver Dis) - No abstract available

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

Pembrolizumab + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Adverse events • Combination therapy • Enrollment open • Melanoma • Oncology • Solid Tumor

[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN IBD: REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (UEGW 2021) - "Switching between CT-P13 and Zessly did not affect treatment efficacy, pharmacokinetics and safety. Moreover, this held true in a double switch group originally treated with Remicade."

Clinical • Real-world evidence • Immunology • Infectious Disease • Inflammatory Bowel Disease • Rheumatology

[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN IBD: REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (UEGW 2021) - "Switching between CT-P13 and Zessly did not affect treatment efficacy, pharmacokinetics and safety. Moreover, this held true in a double switch group originally treated with Remicade."

Clinical • Real-world evidence • Immunology • Infectious Disease • Inflammatory Bowel Disease • Rheumatology

[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN IBD: REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (UEGW 2021) - "Switching between CT-P13 and Zessly did not affect treatment efficacy, pharmacokinetics and safety. Moreover, this held true in a double switch group originally treated with Remicade."

Clinical • Real-world evidence • Immunology • Infectious Disease • Inflammatory Bowel Disease • Rheumatology

What’s Coming Down the Psoriasis Pipeline? – An AAD Reading Room selection (MedPageToday) - "'Bimekizumab seems to have at the very least, a slightly higher efficacy than the other two -- definitely higher than secukinumab, and I believe slightly higher than ixekizumab,' said Dr. Bagel...'Bimekizumab is a monoclonal antibody biologic that targets IL-17A and IL-17F. We don't currently have any other type of drug that blocks those two cytokines,' explained Andrew Blauvelt...'The promise of biosimilars is very attractive, in that everyone wants to have a lower-priced biologic to increase access. What we're seeing, however, in the United States is that the cost reductions are only in the 10-20% range compared to the originator,' explained Dr. Blauvelt....According to Dr. Yamauchi, thus far, roflumilast has little to no side effects. 'Really nothing,' he said. 'No tolerability issues, no stinging or burning. It's a pretty tolerable drug without any significant adverse events.'"

Media quote

Pfizer gets CDSCO panel marketing authorization for Infliximab (Medical Dialogues) - "Granting permission for a local Phase III clinical trial waver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorization to pharmaceutical major Pfizer for a chimeric monoclonal antibody, Infliximab, used in the treatment of a wide variety of inflammatory conditions."

Non-US regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease

Budget Impact of Sequential Treatment with Biologics, Biosimilars, and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Thai Patients with Rheumatoid Arthritis. (PubMed, Adv Ther) - "The order of targeted therapy starting with RTX, then IFX biosimilar, TOF, and finally TCZ incurred the lowest budget impact over a 5-year time horizon for treating moderate to severe RA. Our findings may help payers and policy makers consider appropriate budget allocation on chronic non-communicable diseases, especially RA."

Clinical • HEOR • Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Comparative efficacy and safety of infliximab and its biosimilars in patients with rheumatoid arthritis presenting an insufficient response to methotrexate : A network meta-analysis. (PubMed, Z Rheumatol) - "No significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN INFLAMMATORY BOWEL DISEASE (IBD): REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (DDW 2021) - "The Edinburgh IBD unit has now undertaken two managed switch programmes for infliximab: 1) Remicade to CT-P13 in 2016 and 2) CT-P13 to Zessly in Q1 2020. 5 patients (2%) were switched to another biologic category due to loss of response. Three patients (1.2%) stopped treatment due to adverse events (2 due to rash and 1 due to exacerbation of arthritis).ConclusionsSingle and multiple biosimilar infliximab switching appears to be safe and have no negative effects in clinical outcomes at 6 months."

Clinical • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatology

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis (clinicaltrials.gov) - P3; N=270; Not yet recruiting; Sponsor: University of Erlangen-Nürnberg Medical School

Clinical • New P3 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL22 • LCN2

Grifols launches patient point-of-care system for monitoring infliximab in Europe (PRNewswire) - "Grifols...announced it has begun European commercialization of a two-test point-of-care (POC) system for monitoring a patient's level of infliximab, the medication that treats a variety of chronic inflammatory conditions, as well as the antibodies that could neutralize the drug's efficacy...The tests cover both the reference infliximab (Remicade) and the infliximab biosimilars such as CT-P13 (Inflectra/Remsima), SB2 (Flixabi/Renflexis) and GP1111 (Zessly/Ixifi)."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Network meta-analysis of infliximab biosimilars for the treatment of rheumatoid arthritis. (PubMed, Am J Health Syst Pharm) - "ACR20 response appears to be comparable and nonsignificantly different between infliximab biosimilars. In the absence of any meaningful differences in safety or efficacy, biosimilar cost may be the deciding factor in choosing a treatment or agent for formulary inclusion."

Journal • Retrospective data • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology

FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - P4; N=148; Recruiting; Sponsor: University Medical Center Groningen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

GIANT: Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease (clinicaltrials.gov) - P=N/A; N=63; Completed; Sponsor: Sandoz; Recruiting ➔ Completed; N=1600 ➔ 63; Trial completion date: Jun 2025 ➔ May 2020

Clinical • Enrollment change • Real-World Evidence • Trial completion • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. (PubMed, BioDrugs) - P3; "Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54."

Clinical • Journal • P3 data • Immunology • Rheumatoid Arthritis • Rheumatology

Pain and its impact on functioning and disability in manual wheelchair users with spinal cord injury: a protocol for a mixed-methods study. (PubMed, BMJ Open) - "This study is registered with the South African National Health Research Database (reference GP201806005). This study's findings will be shared in academic conferences and published in scientific peer-reviewed journals."

Clinical • Journal • CNS Disorders • Complement-mediated Rare Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain

Infliximab for Treatment of Ipilimumab Colitis (clinicaltrials.gov) - P2; N=42; Recruiting; Sponsor: Massachusetts General Hospital; Not yet recruiting ➔ Recruiting; Initiation date: Apr 2020 ➔ Aug 2020

Enrollment open • Trial initiation date • Gastrointestinal Disorder • Melanoma • Oncology • Solid Tumor