ReviewBiologics : targets & therapy2017
Biosimilars and the extrapolation of indications for inflammatory conditions.
Review in Biologics : targets & therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 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
37 citing papers in PubMed, 71 citations in OpenAlex.
- Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Trial
- A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Trial
- A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.British journal of clinical pharmacology · 2020Trial
- The Current Use and Future Perspectives of Biosimilars in Pediatric Healthcare: A Narrative Review.Health science reports · 2026Article
- Efficacy, safety, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab intravenously administered to adults with active rheumatoid arthritis and an inadequate response to methotrexate: a phase 3, randomised study.EULAR rheumatology open · 2026Article
- Evaluating the cost-effectiveness of atezolizumab-bevacizumab in advanced hepatocellular carcinoma: Insights from Taiwan.Journal of food and drug analysis · 2025Article
- Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems.Clinical and experimental medicine · 2025Review
- Development of Biosimilar Aflibercept SDZ-AFL.Current therapeutic research, clinical and experimental · 2025Review
- Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Article
- 'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar.Advances in therapy · 2024Review
- Biosimilars in IBD: What Every Clinician Needs to Know.Current gastroenterology reports · 2024Review
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.Advances in therapy · 2024Review
- Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.Clinical drug investigation · 2023Review
- An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review.Ophthalmology and therapy · 2022Review
- Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring.PloS one · 2022Observational
- Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study.ACR open rheumatology · 2021Article
- Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn's Disease: A Prospective Study.Journal of clinical medicine · 2021Article
- Review
- Practical Considerations for Integrating Biosimilars Into Clinical Practice.Journal of the advanced practitioner in oncology · 2021Article
- Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities.Pharmaceuticals (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Regulatory approval and marketing authorization of biosimilars in inflammatory indications are made on a case-by-case and agency-by-agency basis after evaluating the totality of evidence from the entire development program. This totality of the evidence comprises extensive comparative analytical, functional, nonclinical, and clinical pharmacokinetic/pharmacodynamic, efficacy, safety, and immunogenicity studies used by regulators when evaluating whether a product can be considered a biosimilar. Extrapolation reduces or eliminates the need for duplicative clinical studies of the biosimilar but must be justified scientifically with appropriate data. Understanding the concept, application, and regulatory decisions based on the extrapolation of data is important since biosimilars have the potential to significantly impact patient care in inflammatory diseases.
Indexed as
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.