ReviewEuropean journal of clinical pharmacology2019
Regulation of biosimilar medicines and current perspectives on interchangeability and policy.
Review in European journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.
What it found
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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
33 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pharmacists' Perspectives of Biosimilars: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled it
- Pooled it
- Evaluating the feasibility of health care databases for assessing the safety of switching between originator biologics and biosimilars.Journal of managed care & specialty pharmacy · 2026Article
- Regulatory Definitions and Classification of Biosimilar Medications Across the 6 Regions of the World Health Organization: A Scoping Review.JAMA health forum · 2026Article
- Navigating Regulatory Complexities in Biosimilar Approvals and Imports for Autoimmune Disorder Management: A Comparative Analysis of FDA (US), EMA (EU), and CDSCO (India) Guidelines.Recent advances in drug delivery and formulation · 2026Article
- Demand- Versus Supply-Side Policies in Market Penetration of Biosimilars: Which is More Effective?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Comparing Long-Term Infliximab Persistence Following a Switch to a Biosimilar in Patients With Inflammatory Bowel Disease: No Cause for Concern.Journal of gastroenterology and hepatology · 2025Article
- Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Article
- Biosimilars in the Era of Artificial Intelligence-International Regulations and the Use in Oncological Treatments.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Cancer treatment with biosimilar drugs: A review.Cancer innovation · 2024Review
- The impact of financial incentives promoting biosimilar products in oncology: A quasi-experimental study using administrative data.PloS one · 2024Article
- Biosimilars in Dermatology Review.Journal of psoriasis and psoriatic arthritis · 2024Review
- Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Article
- Factors that Influence Healthcare Professionals' Intentions towards Biosimilars.Innovations in pharmacy · 2024Article
- Riding the Wave of Adalimumab Biosimilars: Considerations for Pediatric Gastroenterologists.Journal of pediatric gastroenterology and nutrition · 2023Article
- Review
- No two classes of biosimilars: Urgent advice to the US Congress and the FDA.Journal of clinical pharmacy and therapeutics · 2022Review
- Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer.Biomedicines · 2022Review
- Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?Patient related outcome measures · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.
Indexed as
Identifiers
30187103What 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.