ReviewBiotechnology and bioengineering2017
Biosimilars: Key regulatory considerations and similarity assessment tools.
Review in Biotechnology and bioengineering, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 2 of them syntheses 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
73 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Patients' Perceptions of Biosimilars: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Pooled it
- Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled it
- Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT-P47 and Reference Tocilizumab: A Randomized, Double-Blind, Phase 1 Study.Journal of clinical pharmacology · 2025Trial
- Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (NovologBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Trial
- A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin's Ranibizumab with LucentisIndian journal of ophthalmology · 2022Trial
- 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
- From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars.Bioanalysis · 2026Article
- Review of Quality Attributes and Analytical Methods Used for Comparative Analytical Assessment of Monoclonal Antibodies as Part of Successful Biosimilar Approvals in the United States and European Union.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Biosimilars of anti-VEGF agents in retinal diseases: a narrative review of regulatory, clinical, and pharmacoeconomic aspects.International journal of retina and vitreous · 2026Review
- Dose reduction and discontinuation of non-tumor necrosis factor (TNF) biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for people with rheumatoid arthritis in remission or low disease activity.The Cochrane database of systematic reviews · 2026Article
- The Current Use and Future Perspectives of Biosimilars in Pediatric Healthcare: A Narrative Review.Health science reports · 2026Article
- Current GMP standards for the large-scale production of monoclonal antibodies.Bioengineering & translational medicine · 2026Review
- Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye.Drugs & aging · 2026Review
- Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin).Pharmaceutics · 2026Article
- Comparing the pharmacokinetics of adalimumab originator and biosimilar product in patients with Inflammatory bowel disease or autoimmune disease.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Article
- On the achievable consistency of glycan distribution in biomanufacturing of therapeutic mAbs.NPJ advanced manufacturing · 2026Article
- Migraine, monoclonal antibodies, and monitoring: a review of pharmacovigilance in the era of biologics.Frontiers in pharmacology · 2026Review
- Biochemical and Biophysical Divergences between TwoBiochemistry · 2025Article
- Interrogation of Structure-Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Anti-Adalimumab Antibodies Purified from Juvenile Idiopathic Arthritis Patients: Kinetic Characterization Among Biosimilars.Biosensors · 2025Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences in purity, potency, and safety between the two products. The development of biosimilars is a challenging, multistep process. Typically, the assessment of similarity involves comprehensive structural and functional characterization throughout the development of the biosimilar in an iterative manner and, if required by the local regulatory authority, an in vivo nonclinical evaluation, all conducted with direct comparison to the reference product. In addition, comparative clinical pharmacology studies are conducted with the reference product. The approval of biosimilars is highly regulated although varied across the globe in terms of nomenclature and the precise criteria for demonstrating similarity. Despite varied regulatory requirements, differences between the proposed biosimilar and the reference product must be supported by strong scientific evidence that these differences are not clinically meaningful. This review discusses the challenges faced by pharmaceutical companies in the development of biosimilars.
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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.