ReviewBritish journal of clinical pharmacology2015
Biosimilar: what it is not.
Review in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- An update on the clinical evidence that supports biosimilar approvals in Europe.British journal of clinical pharmacology · 2018Pooled it
- Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects.Pharmacology research & perspectives · 2018Trial
- Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects.British journal of clinical pharmacology · 2017Trial
- Biosimilars: A Virtuous Cycle of Sustainability and Innovation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Toward the Development of a Biosimilar Variant of Glucarpidase (Carboxypeptidase G2): Secretory Production, Optimization, and Immobilization.Molecular biotechnology · 2026Article
- Navigating the Biosimilars from Bench to Bedside in Juvenile Idiopathic Arthritis.Paediatric drugs · 2025Review
- An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.Pharmaceuticals (Basel, Switzerland) · 2024Review
- The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis.Intestinal research · 2023Review
- The whole experience of public hospital physicians from several specialties with biopharmaceutical effectiveness, safety, adverse drug reactions and interchangeability: A qualitative study.Exploratory research in clinical and social pharmacy · 2022Article
- Facile imprinted polymer for label-free highly selective potentiometric sensing of proteins: case of recombinant human erythropoietin.Analytical and bioanalytical chemistry · 2021Article
- Safety of Ovaleap® (Follitropin Alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies: A Multinational Comparative, Prospective Cohort Study.Frontiers in endocrinology · 2021Article
- Similar biologics in India: A story of access or potential for compromise?The Indian journal of medical research · 2020Review
- Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn's Disease.PharmacoEconomics · 2019Article
- Review
- Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment.Bioengineering (Basel, Switzerland) · 2019Article
- Biologics, biosilimars, and biobetters: different terms or different drugs?Eye (London, England) · 2019Review
- Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq.Open access rheumatology : research and reviews · 2019Review
- Unmet Needs in the Field of Psoriasis: Pathogenesis and Treatment.Clinical reviews in allergy & immunology · 2018Review
- Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product.Pharmaceutical research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A biosimilar is a high quality biological medicine shown to be in essence the same as an original product. The European Medicines Agency (EMA) paved the way in the regulatory arena by creating a safeguarding framework for the development of biosimilars. Biosimilar is thus a regulatory term that alludes to the evidence-based studies required to demonstrate such very high similarity. They are therefore not innovative products but the pathway laid down by the EMA for their approval represented a new paradigm. This has brought some confusion and has cast doubts among healthcare professionals about the scientific evidence behind their authorization. Many papers have been published to clarify the concept, and to reassure those professionals, but misconceptions frequently still arise. Unfortunately, this prevents biosimilars from deploying their full therapeutic added value. This paper is intended to approach those misconceptions from a new angle, by explaining what a biosimilar is not…and why. A biosimilar is neither a generic, nor an original product. It is not a biobetter or a 'stand-alone'. Therefore, it should not be managed as such therapeutically, commercially or from a healthcare policy viewpoint. The EMA's criteria were acknowledged by other agencies, but a significant regulatory gap with a vast majority of regulatory bodies still remains. This leaves room for the so-called non-original biologics (NOB), i.e. non-biosimilar biologics, to be launched in many regions. Raising awareness of what a biosimilar is and what it is not, will generate trust in biosimilars among healthcare professionals and will ultimately benefit patients.
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.