ReviewRheumatology international2016
Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology.
Review in Rheumatology international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 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
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye.Drugs & aging · 2026Review
- Analysis of data on biosimilar prescription rates in rheumatology practice from a reference center in Turkey.Scientific reports · 2025Article
- Nano-based Therapeutics for Rheumatoid Arthritis: Recent Patents and Development.Recent patents on nanotechnology · 2025Review
- Patient's and Consultant's Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study.Pharmacy (Basel, Switzerland) · 2024Article
- Drug Delivery System Approaches for Rheumatoid Arthritis Treatment: A Review.Mini reviews in medicinal chemistry · 2024Review
- Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer's Perspective.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.Haematologica · 2023Review
- 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
- An Institutional Guide for Formulary Decisions of Biosimilars.Hospital pharmacy · 2023Review
- Advancing Biologic Therapy for Refractory Autoimmune Hepatitis.Digestive diseases and sciences · 2022Review
- 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
- Review
- The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring.Frontiers in immunology · 2021Article
- Health technology assessment of biosimilars worldwide: a scoping review.Health research policy and systems · 2020Article
- Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview.Biomedicines · 2020Review
- Real-Life Tolerability and Effectiveness of Adalimumab Biosimilar in Rheumatoid Arthritis: ASPIRE Registry Data.Rheumatology and therapy · 2019Article
- Review
- Biosimilars in dermatology: The wind of change.Experimental and therapeutic medicine · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biologics are vital to the management of patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions. Nevertheless, access to these highly effective treatments remains an unmet medical need for many people around the world. As patents expire for existing licensed biologic (originator) products, biosimilar products can be approved by regulatory authorities and enter clinical use. Biosimilars are highly similar copies of originator biologics approved through defined and stringent regulatory processes after having undergone rigorous analytical, non-clinical, and clinical evaluations. The introduction of high-quality, safe, and effective biosimilars has the potential to expand access to these important medicines. Biosimilars are proven to be similar to the originator biologic in terms of safety and efficacy and to have no clinically meaningful differences. In contrast, "intended copies" are copies of originator biologics that have not undergone rigorous comparative evaluations according to the World Health Organization recommendations, but are being commercialized in some countries. There is a lack of information about the efficacy and safety of intended copies compared with the originator. Furthermore, they may have clinically significant differences in formulation, dosages, efficacy, or safety. In this review, we explore the differences between biosimilars and intended copies and describe key concepts related to biosimilars. Familiarity with these topics may facilitate decision making about the appropriate use of biosimilars for patients with rheumatic and musculoskeletal 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.