ReviewDrugs2017
The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects.
Review in Drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 4 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
51 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence.International journal of clinical pharmacy · 2025Pooled it
- Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review.Advances in therapy · 2019Pooled it
- Efficacy and Safety in the Continued Treatment With a Biosimilar Drug in Patients Receiving Infliximab: A Systematic Review in the Context of Decision-Making From a Latin-American Country.Frontiers in pharmacology · 2019Pooled it
- Nocebo in Biosimilars and Generics in Neurology: A Systematic Review.Frontiers in pharmacology · 2019Pooled it
- Comparison of the efficacy and safety of SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration.Scientific reports · 2024Trial
- Trial
- Ten-Year Public Expenditure Savings Associated with TNF Inhibitor Biosimilars under Australia's Pharmaceutical Benefits Scheme.Clinical pharmacology and therapeutics · 2026Article
- Biosimilars of anti-VEGF agents in retinal diseases: a narrative review of regulatory, clinical, and pharmacoeconomic aspects.International journal of retina and vitreous · 2026Review
- Evidence for the use of anti-CD20 therapeutic antibodies in immune thrombotic thrombocytopenic purpura management: a review.Frontiers in pharmacology · 2026Review
- Financial reimbursement incentives in the use of biosimilars for rheumatoid arthritis in Japan.Journal of pharmaceutical policy and practice · 2026Article
- Knowledge and Attitude of Aseer Region Pharmacists Toward Biosimilar Medicines: A Descriptive Study.Healthcare (Basel, Switzerland) · 2025Article
- Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study.Pharmaceutical medicine · 2025Article
- Immunogenicity Risk Assessment of Biotherapeutics Using an Ex Vivo B Cell Assay.Antibodies (Basel, Switzerland) · 2025Article
- Cost-effectiveness of HLX01 (HanlikangFrontiers in pharmacology · 2025Article
- Review
- Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review.Advances in therapy · 2024Review
- A Regulatory Perspective on Biosimilar Medicines.Pharmaceutics · 2024Review
- An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Highly purified charge variants of a proposed biosimilar to Omalizumab: impact on in vitro potency and stability under thermal stress.Bioprocess and biosystems engineering · 2024Article
- Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials.Journal of diabetes science and technology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attributes, efficacy, safety, and immunogenicity compared with an existing licensed, originator biologic. As more biosimilars receive regulatory approval and reach the market, it is increasingly important for healthcare providers to understand the terminology about biosimilars. To help support healthcare providers, the aim of this manuscript is to (i) support understanding of the language of biosimilars, (ii) review the regulatory and manufacturing processes employed in developing a biosimilar, and (iii) provide information for clinical decisions about the use of biosimilars. Because biologics are large, structurally complex proteins, biosimilars cannot be considered generic equivalents to the originator. Biosimilars are developed and evaluated using rigorous processes involving detailed analytical and functional studies, nonclinical assessments, and clinical trials. Clinical studies evaluating the potential biosimilar are designed differently than those for approval of a novel biologic since the aim is merely to confirm similar efficacy and safety and not to demonstrate clinical benefit per se. Extrapolation of data may be used to grant approval of biosimilars in indications not directly evaluated in clinical studies using the biosimilar.
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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.