ArticleDrug design, development and therapy2022
Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars.
Article in Drug design, development and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed.
- FDA's Approval Summary of the First Biosimilar to Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease.Journal of clinical pharmacology · 2026Article
- Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization.Frontiers in medicine · 2026Review
- The FDA's adoption of Bayesian methodology: transforming clinical trial justification from biosimilars to broader drug development.Frontiers in medicine · 2026Review
- Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks.Frontiers in drug delivery · 2026Review
- Knowledge and Attitude of Aseer Region Pharmacists Toward Biosimilar Medicines: A Descriptive Study.Healthcare (Basel, Switzerland) · 2025Article
- Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Placebo Effects: Neurological Mechanisms Inducing Physiological, Organic, and Belief Responses-A Prospective Analysis.Healthcare (Basel, Switzerland) · 2024Article
- Advice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Pooled analysis of three pharmacokinetic studies comparing biosimilar MB02 and reference bevacizumab.Pharmacology research & perspectives · 2023Article
- A Critical Analysis of the FDA's Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity.Pharmaceuticals (Basel, Switzerland) · 2023Review
- 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 in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.Haematologica · 2023Review
- Biosimilars Adoption: Recognizing and Removing the RoadBlocks.ClinicoEconomics and outcomes research : CEOR · 2023Article
- Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars.Journal of market access & health policy · 2023Article
- The Inflation Reduction Act: A boon for the generic and biosimilar industry.Journal of clinical pharmacy and therapeutics · 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
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
After 18 years and the administration of billions of doses, there is little doubt about biosimilars' safety and efficacy. Yet, only 14 molecules in the EU and 9 in the US are available as biosimilars, among the 200+ targets, due mainly to the high development cost attributed to clinical efficacy testing after extensive analytical assessment, nonclinical testing, and clinical pharmacology comparisons. So far, none of the hundreds of clinical efficacy testing has failed because it cannot fail due to its lack of sensitivity for multiple reasons, as argued in this paper. This analysis is unique since biosimilars are the first category of products that are put to comparative testing as if these were new biological drugs. Clinical efficacy testing used to overcome differences in the analytical, nonclinical, and clinical pharmacology comparisons can lead to the approval of unsafe products. Only recently the regulatory agencies have begun to talk about this risk and shown their willingness to waive these studies. However, a clear change in the regulatory guidelines is required to change the mindset of all biosimilar stakeholders to bring a pivotal change in the availability of affordable biosimilars.
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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.