ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2019
Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed.
- Re-engineering insulin for oral delivery: structural modifications, advanced formulation strategies, and future directions.Drug delivery · 2026Review
- The Nuances Surrounding Insulin Prescribing.Clinical diabetes : a publication of the American Diabetes Association · 2023Article
- Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Article
- Using the Power of Junctional Adhesion Molecules Combined with the Target of CAR-T to Inhibit Cancer Proliferation, Metastasis and Eradicate Tumors.Biomedicines · 2022Article
- Who Will Be Responsible for the Dialysis Bill? A Case Report and Narrative Review of Insulin Affordability 100 Years After the Discovery of Insulin.Journal of general internal medicine · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians.
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.