ArticleTargeted oncology2012
Biosimilar rhG-CSFs: how similar are they?
Article in Targeted oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Trial
- Article
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
Biosimilars are more affordable copycat versions of originator biological products in much the same way as generics are copies of small molecule pharmaceuticals. However, while generics are approved on the basis of structural and pharmacokinetic equivalence, the intricate structure of biological medicinal products and the complex nature of their manufacturing process in living organisms impose a separate, and more stringent, regulatory approval process. The aims of this article are (a) to discuss key aspects of the development process and authorization requirements for biosimilars in Europe using published comparative physicochemical and clinical data for EU-approved recombinant human granulocyte colony stimulating factor (rhG-CSF) biosimilars, the most recent addition to the therapeutic category of hematopoietic growth factors, and (b) to demonstrate that the rigorous scientific evaluation process is designed to ensure that their clinical safety and efficacy is not compromised by the abbreviated development program.
Indexed as
Identifiers
22318351What 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.