ReviewJournal of clinical pharmacy and therapeutics2022
No two classes of biosimilars: Urgent advice to the US Congress and the FDA.
Review in Journal of clinical pharmacy and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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
10 citing papers in PubMed.
- The FDA's adoption of Bayesian methodology: transforming clinical trial justification from biosimilars to broader drug development.Frontiers in medicine · 2026Review
- Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization.Frontiers in medicine · 2026Review
- Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- The FDA's New Guideline "Generally Accepted Scientific Knowledge" (GASK): An Opportunity to Expedite the Approval of Biosimilars.Pharmaceuticals (Basel, Switzerland) · 2023Review
- A Proposed Global Medicines Agency (GMA) to Make Biological Drugs Accessible: Starting with the League of Arab States.Healthcare (Basel, Switzerland) · 2023Review
- Biosimilars Adoption: Recognizing and Removing the RoadBlocks.ClinicoEconomics and outcomes research : CEOR · 2023Article
- Molecular Biosimilarity-An AI-Driven Paradigm Shift.International journal of molecular sciences · 2022Review
- No two classes of biosimilars: Urgent advice to the US Congress and the FDA.Journal of clinical pharmacy and therapeutics · 2022Review
- Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars.Drug design, development and therapy · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
WHAT IS KNOWN AND
objectiveThe United States is the only country with legislation to approve two classes of biosimilars. One has "no clinically meaningful difference" from the reference product, and when it is tested for switching and alternating, it can receive an interchangeable status. The objective of this review is to establish whether it is possible from the switching and alternating studies to evaluate additional safety or efficacy.
methodsAnalysed published data to ascertain if the testing with switching and alternating provide additional proof of safety or efficacy. Political and scientific rationale of creating a new class of biosimilars and how this affects the confidence in biosimilars. RESULTS AND DISCUSSION: There is no safety or efficacy concern when switching or alternating biosimilars with the reference product. Unfortunately, the rationale for interchangeability is more political than scientific, and it has brought more confusion and mistrust in using biosimilars in the United States. WHAT IS NEW AND
conclusionThe US Congress is requested to remove the interchangeability clause from the Biological Price and Competition Act to enable faster acceptance of biosimilars and remove the threat of lack of confidence in the safety of biosimilars.
Indexed as
Identifiers
What Socratic 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 Socratic graph.