ArticleEuropean journal of clinical pharmacology2018
Degree of prescriber's knowledge about variability in biological drugs "innovators" in manufacturing process.
Article in European journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy, safety and immunogenicity of etanercept biosimilarsFrontiers in pharmacology · 2023Pooled it
- Switching Among Biosimilars: A Review of Clinical Evidence.Frontiers in pharmacology · 2022Article
- Clinical evidence supporting the marketing authorization of biosimilars in Europe.European journal of clinical pharmacology · 2020Review
- Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease.Therapeutic advances in gastroenterology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe purpose of the study is to analyse the degree of prescribers' knowledge about the regulation and variability in manufacturing processes (MP) in bio-drugs "innovators" (BI).
methodsFor each selected drugs, the date of authorization by the European Medicines Agency, time elapsed until the first change, total number of changes and annual rate of change (ARC) were recorded. A survey was designed with 4 parts: (a) identifying the BI prescribed; (b) knowledge of the number and ARC of each BI during its MP; (c) knowledge of comparability requirement of BI before or after the MP; (d) evaluating the utility of the information in the survey.
resultsDrugs selected and total number of changes: infliximab (41), adalimumab (20), abatacept (13), golimumab (7), etanercept (18), tocilizumab (6) and certolizumab. All BI had been changed in the MP after their authorisation. The survey was answered by 35 professionals from rheumatology, digestive and dermatology area. They had prescribed one or more drugs included in the survey at least once. Sixty-three percent of prescribers did not know the existence of changes relative to the MP. Thirty-seven percent of prescribers knew of their existence, but not about number or frequency. Fifty-seven percent of prescribers did not know the regulation about the comparability among BI. The rest of them knew it, but 29% related it only to biosimilar drugs. Ninety-four percent of prescribers identified information as useful.
conclusionBI present a high ARC during their MP after their commercialization, without any efficacy or safety difficulties. Knowledge of this might increase confidence for biosimilars.
Indexed as
Identifiers
29247389What 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.