ReviewBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2017
Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.
Review in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 2 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
45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024Pooled it
- Patients' perspectives on the relevance of biosimilars' outcomes in oncology: qualitative study with nominal group technique.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Pooled it
- New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double-Blind, Parallel-Group, Single-Dose Trial in Healthy Subjects.Clinical pharmacology in drug development · 2024Trial
- Trial
- Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Trial
- A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.British journal of clinical pharmacology · 2020Trial
- An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis.Arthritis research & therapy · 2019Trial
- Statistical Tools for Biosimilarity Assessment: A Perspective Based on WHO-recommended Approaches.The AAPS journal · 2026Article
- Development and preliminary physicochemical characterization of a Ramucirumab biosimilar candidate in CHO cells using shake-flask fed-batch culture.Bioprocess and biosystems engineering · 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
- Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections.Pharmaceutics · 2025Review
- Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements - Outcomes of a Descriptive Review.Therapeutic innovation & regulatory science · 2025Review
- Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.AAPS PharmSciTech · 2025Review
- Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product.Ophthalmology and therapy · 2025Article
- Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product.Ophthalmology and therapy · 2024Article
- 'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar.Advances in therapy · 2024Review
- Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability.Molecular pharmaceutics · 2024Article
- An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.Advances in therapy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biosimilars are highly similar versions of approved branded biologics. Unlike generics, they are not exact replicas of reference products. Minor differences between biosimilars and reference products in some aspects are expected; likewise, biosimilar products will differ from each other. The objective of this review is to discuss the challenges associated with the development and approval of biosimilar products that are unique because of their complex structure and specialized manufacturing processes, which can impact not only efficacy but also immunogenicity and safety. Regulatory guidelines recommend a totality-of-evidence approach focused on stepwise development that involves demonstration of structural similarity and functional equivalence. Structural and functional characteristics of the proposed biosimilar are compared with the reference product; similarity of these functions forms the foundation of the biosimilar development program, including potential animal studies, a human pharmacokinetics/pharmacodynamics equivalence study, and a clinical study to confirm similar efficacy, safety, and immunogenicity. The clinical study should be performed in a sensitive population using appropriate endpoints to allow detection of any clinically meaningful differences between the biosimilar and the reference product if such differences exist. In conclusion, development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product and the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar product.
Indexed as
Identifiers
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.