ArticleAdvances in therapy2016
Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade
Article in Advances in therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 36 citations in OpenAlex.
- A comparative study of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis.International journal of rheumatic diseases · 2020Trial
- 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.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Trial
- Trial
- A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.Arthritis research & therapy · 2018Trial
- Cross-Species Extrapolation of Neonatal Fc Receptor (FcRn) Binding Affinity to Predict Monoclonal Antibody Pharmacokinetics in Humans Using Physiologically Based Pharmacokinetic Modeling (PBPK): Are We There Yet?ACS pharmacology & translational science · 2025Article
- Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Efficacy, Safety, and Cost-Effectiveness of the Infliximab Biosimilar GP-1111 in Patients with Inflammatory Bowel Disease Who Underwent a Nonmedical Switch: A Prospective Cohort Study.Biologics : targets & therapy · 2025Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- A Review of the Occurrence of Rheumatoid Arthritis and Potential Treatments through Medicinal Plants from an Indian Perspective.Current rheumatology reviews · 2024Review
- Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis.RMD open · 2022Article
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- PAID study design on the role of PKC activation in immune/inflammation-related depression: a randomised placebo-controlled trial protocol.General psychiatry · 2021Article
- Assessing the Extended In-Use Stability of the Infliximab Biosimilar PF-06438179/GP1111 Following Preparation for Intravenous Infusion.Drugs in R&D · 2019Article
- Monoclonal Antibodies Targeting Ion Channels and Their Therapeutic Potential.Frontiers in pharmacology · 2019Review
- The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product.Therapeutic advances in gastroenterology · 2019Review
- PF-06438179/GP1111: An Infliximab Biosimilar.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Review
- A review of the literature analyzing benefits and concerns of infliximab biosimilar CT-P13 for the treatment of rheumatologic diseases: focus on interchangeability.Drug design, development and therapy · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPF-06438179, a potential biosimilar to Remicade
methodsAnalytical (small subset reported here) and nonclinical studies compared the structural, functional, and in vivo nonclinical similarity of PF-06438179 with Remicade sourced from the United States (infliximab-US) and/or European Union (infliximab-EU).
resultsThe peptide map profiles were superimposable, and peptide masses were the same, indicating identical amino acid sequences. Data on post-translational modifications, biochemical properties, and biological function provided strong support for analytical similarity. Administration of a single intravenous (IV) dose (10 or 50 mg/kg) of PF-06438179 or infliximab-EU to male rats was well tolerated. There were no test article-related clinical signs or effects on body weight or food consumption. Systemic exposures [maximum drug concentration (C
conclusionsThe analytical and nonclinical studies have supported advancement of PF-06438179 into global comparative clinical trials.
fundingPfizer Inc.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.