ReviewBritish journal of clinical pharmacology2013
Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?
Review in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- An update on the clinical evidence that supports biosimilar approvals in Europe.British journal of clinical pharmacology · 2018Pooled it
- Clinical trials for authorized biosimilars in the European Union: a systematic review.British journal of clinical pharmacology · 2016Pooled it
- Innovative highlights of clinical drug trial design.Translational research : the journal of laboratory and clinical medicine · 2020Review
- Biosimilar and interchangeable: Inseparable scientific concepts?British journal of clinical pharmacology · 2019Article
- Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod.Drug design, development and therapy · 2016Review
- Biosimilar: what it is not.British journal of clinical pharmacology · 2015Review
- In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches.The AAPS journal · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The effectiveness and safety of generic drugs are backed by sound physicochemical control and regulatory bioequivalence acceptance criteria. Statistical testing of bioequivalence, comparing the pharmacokinetic profiles of the test and reference products, was made possible by modern drug assays. When the pharmacokinetic profile correlates with the dose, such comparisons show assay sensitivity and readily detect differences in dose. For large biological molecules, different manufactured batches cannot be validated using pharmacokinetic data alone. For these biosimilars, there is a three-stage assessment of pharmaceutical quality, laboratory testing and clinical data. This approach has also been applied to certain chemical products, termed 'chemisimilars', which have variable or complex synthesis of the active substance, or complex formulation, or a complex delivery device. Although there may be no detectable difference between the test and reference on clinical testing, many of the outcome measures are insensitive to even large differences in dose. For testing to be fit for purpose it should distinguish important dose differences, but many clinical tests of chemisimilars and biosimilars do not. As pharmacokinetic and pharmacodynamic technology advances, the trend of replacing dose-insensitive clinical trial data with equivalence tests that show assay sensitivity can be expected to continue.
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.