ReviewDiabetes technology & therapeutics2012
The emergence of biosimilar insulin preparations--a cause for concern?
Review in Diabetes technology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.
- Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.PloS one · 2018Pooled it
- Biosimilar insulins: Narrative review of the regulatory framework and registration studies.Diabetes, obesity & metabolism · 2025Review
- Reduction in C-Peptide Levels and Influence on Pharmacokinetics and Pharmacodynamics of Insulin Preparations: How to Conduct a High-Quality Euglycemic Clamp Study.Frontiers in pharmacology · 2021Article
- Anti-Contamination Strategies for Yeast Fermentations.Microorganisms · 2020Review
- Nanomedical Relevance of the Intermolecular Interaction Dynamics-Examples from Lysozymes and Insulins.ACS omega · 2019Article
- In Response to Letters to the Editor From the American Diabetes Association and Eli Lilly in Regard to: Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain.Journal of diabetes science and technology · 2018Article
- Article
- Introduction of biosimilar insulins in Europe.Diabetic medicine : a journal of the British Diabetic Association · 2017Review
- How Similar Are Biosimilars? What Do Clinicians Need to Know About Biosimilar and Follow-On Insulins?Clinical diabetes : a publication of the American Diabetes Association · 2017Article
- Ultra-high resolution X-ray structures of two forms of human recombinant insulin at 100 K.Chemistry Central journal · 2017Article
- Article
- Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or LantusDiabetes therapy : research, treatment and education of diabetes and related disorders · 2017Article
- Recombinant Human Insulin in Global Diabetes Management - Focus on Clinical Efficacy.European endocrinology · 2017Review
- Quality Control of Insulins and Biosimilar Insulins: What Do We Know?Journal of diabetes science and technology · 2016Article
- Biosimilar insulins: guidance for data interpretation by clinicians and users.Diabetes, obesity & metabolism · 2015Review
- Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices.Drug safety · 2015Review
- An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins.Diabetes technology & therapeutics · 2015Review
- Equivalent Recombinant Human Insulin Preparations and their Place in Therapy.European endocrinology · 2015Review
- Why is there no generic insulin? Historical origins of a modern problem.The New England journal of medicine · 2015Article
- Biosimilar Insulins: Basic Considerations.Journal of diabetes science and technology · 2014Article
Corrections and comments
- Commented on by
Authors and funding
5 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Several biopharmaceuticals, including insulin and insulin analogs, are, or shortly will be, off-patent, thereby providing an opportunity for companies to attempt to manufacture "copies" commonly referred to as biosimilars and also known as follow-on biologics. Reassurance that such copy biologics are equally safe and effective as the conventional products is essential. It is important for the clinician to consider what information is therefore necessary for such assurances. Biopharmaceuticals, produced from living organisms and manufactured by complex processes, differ in many respects from chemically derived drugs. The biological source materials and manufacturing processes for non-innovator biologics may differ considerably from those used for producing the innovator substance. Differences between innovator and non-innovator products can be identified analytically (e.g., batch-to-batch consistency, product stability along side clinical safety). This provides a strong argument for caution before automatic substitution of conventional products (e.g., insulin by biosimilars). Several non-innovator insulins, including insulin analogs (while still patent-protected), are already available in many countries. Many of these lack rigorous regulations for biosimilar approval and pharmacovigilance. Recently an application for a biosimilar recombinant human insulin was withdrawn by the European Medicines Agency because of safety and efficacy concerns. Therefore, every biosimilar insulin and insulin analog should be assessed by well-defined globally harmonized preclinical and clinical studies followed by post-marketing pharmacovigilance programs, in the interest of people with diabetes worldwide.
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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.