ReviewAmerican journal of therapeutics
Statistical Primer on Biosimilar Clinical Development.
Review in American journal of therapeutics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03729674 (Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs), which is not on this map. Cited by 16 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.
Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs
Who cites it
16 citing papers in PubMed.
- A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects.BMC pharmacology & toxicology · 2019Trial
- Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer.British journal of cancer · 2018Trial
- Statistical Tools for Biosimilarity Assessment: A Perspective Based on WHO-recommended Approaches.The AAPS journal · 2026Article
- Relapse of retinal vasculitis after a non-medical biosimilar switch: a case report.Journal of ophthalmic inflammation and infection · 2026Article
- The Role of Outcome Response Rate in Planning Biosimilar Studies Using Different Evaluation Metrics.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Biosimilars in Dermatology Review.Journal of psoriasis and psoriatic arthritis · 2024Review
- Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC.JTO clinical and research reports · 2022Article
- The Totality of Evidence and Use of ABP 215, a Biosimilar to Bevacizumab.Oncology and therapy · 2021Article
- Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Review
- The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars.British journal of cancer · 2019Review
- Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future.Dermatology and therapy · 2018Review
- Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars.Targeted oncology · 2017Review
- Review
- A practical guide about biosimilar data for health care providers treating inflammatory diseases.Biologics : targets & therapy · 2017Review
- Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.
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.