ReviewBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2020
The Path Towards a Tailored Clinical Biosimilar Development.
Review in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis 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
29 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled it
- From Reflection to Implementation: Tailored Clinical Development of a Pembrolizumab Biosimilar Candidate.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- Importance of Single Global Regulatory Standards for the Assessment of Generic and Biosimilar Medicines to Advance Patient Access.The AAPS journal · 2026Article
- Fundamental changes in regulation to improve access to biosimilars.Bulletin of the World Health Organization · 2026Article
- From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars.Bioanalysis · 2026Article
- From analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development.Bioanalysis · 2026Review
- Article
- Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Review
- Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements - Outcomes of a Descriptive Review.Therapeutic innovation & regulatory science · 2025Review
- Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.The AAPS journal · 2024Review
- Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product KeytrudaDrugs in R&D · 2024Article
- Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.Pharmaceutical medicine · 2024Article
- Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Review
- 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
- Article
- Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars.Journal of market access & health policy · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since the first approval of a biosimilar medicinal product in 2006, scientific understanding of the features and development of biosimilar medicines has accumulated. This review scrutinizes public information on development programs and the contribution of the clinical studies for biosimilar approval in the European Union (EU) and/or the United States (US) until November 2019. The retrospective evaluation of the programs that eventually obtained marketing authorization and/or licensure revealed that in 95% (36 out of 38) of all programs, the comparative clinical efficacy studies confirmed similarity. In the remaining 5% (2 out of 38), despite meeting efficacy outcomes, the biosimilar candidates exhibited clinical differences in immunogenicity that required changes to the manufacturing process and additional clinical studies to enable biosimilar approval. Both instances of clinical differences in immunogenicity occurred prior to 2010, and the recurrence of these cases is unlikely today due to state-of-the-art assays and improved control of process-related impurities. Biosimilar candidates that were neither approved in the EU nor in the US were not approved due to reasons other than clinical confirmation of efficacy. This review of the development history of biosimilars allows the proposal of a more efficient and expedited biosimilar development without the routine need for comparative clinical efficacy and/or pharmacodynamic studies and without any compromise in quality, safety, or efficacy. This proposal is scientifically valid, consistent with regulation of all biologics, and maintains robust regulatory standards in the assessment of biosimilar candidates. Note: The findings and conclusion of this paper are limited to biosimilar products developed against the regulatory standards in the EU and the US.
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.