ReviewAdvances in therapy2021
The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable.
Review in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 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
20 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Pooled it
- Impact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis.Scientific reports · 2023Pooled it
- Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Pooled it
- Article
- Financial Toxicity Associated with Biological Medicines: A Scoping Review.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
- 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
- Patient knowledge and acceptance of the upcoming automatic substitution of biological medicines in community pharmacies: survey of Finnish patients with inflammatory bowel disease and psoriasis.BMC health services research · 2025Article
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.AAPS PharmSciTech · 2025Review
- Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America.Advances in therapy · 2024Review
- An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Biosimilars in Dermatology Review.Journal of psoriasis and psoriatic arthritis · 2024Review
- Exploring the Influence of Health Insurance Plans on Biosimilar Adoption Rates.PharmacoEconomics - open · 2024Article
- Assessment of Reported Adverse Events After Interchanging Between TNF-α Inhibitor Biosimilars in the WHO Pharmacovigilance Database.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- An international comparative analysis and roadmap to sustainable biosimilar markets.Frontiers in pharmacology · 2023Article
- Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption.Medicina (Kaunas, Lithuania) · 2022Review
- Under the Umbrella of Clinical Pharmacology: Inflammatory Bowel Disease, Infliximab and Adalimumab, and a Bridge to an Era of Biosimilars.Pharmaceutics · 2022Review
- An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review.Ophthalmology and therapy · 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
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority links interchangeability to automatic substitution, as all require the involvement of the prescriber or patient in a medication change. This editorial considers the clinical impact and practicality of auto-substitution. First, interchangeability is linked to non-medical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons. NMS may generate negative sentiment in those unwilling or reluctant to switch, which can adversely impact treatment outcomes (i.e., nocebo effect). Indeed, in real-world studies of tumor necrosis factor inhibitors, discontinuation rates have been shown to be higher in patients switched to biosimilars for non-medical reasons than in historical cohorts maintained on innovators. Second, interchangeability may impede pharmacovigilance and traceability, as not all jurisdictions require innovators and biosimilars to have distinct biologic names. Third, an interchangeability designation from the US Food and Drug Administration only permits a biosimilar to be automatically substituted for its innovator, not other biosimilars (if available). Pharmacist education would be needed to avoid off-label, automatic substitution among biosimilars of a single innovator. Last, once granted, an interchangeability designation exists in perpetuity under current US federal law. However, the supply chains of innovators and biosimilars are maintained independently, with no requirement for reconfirmation of biosimilarity or interchangeability. We feel that additional guidance is needed for the auto-substitution of biosimilars and innovators to become a reality.
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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.