Bibliographic record
Abstract
Biosimilars are biological products that are very similar, but not identical, to an originator product. For anti-TNF biosimilars for inflammatory bowel disease treatment, a number of concerns have been raised by pharmacologists and gastroenterologists with respect to the evaluation of biosimilarity, product stability, production condition stability, biosimilar name, extrapolation of indications, traceability, interchangeability and pharmacovigilance. These points will be discussed in this review. There are several questions that have not been satisfactorily answered so far, leading to different regulatory guidelines in Europe (European Medicines Agency), the USA (Food and Drug Administration), Canada and other countries. For clinicians, it will be important to have knowledge about these concerns to make reasonable patient-oriented decisions in the upcoming confusing market of biosimilars for established anti-TNF antibodies.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.025 | 0.070 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.003 | 0.011 |
| Scholarly communication | 0.007 | 0.017 |
| Open science | 0.004 | 0.005 |
| Research integrity | 0.016 | 0.020 |
| Insufficient payload (model declined to judge) | 0.031 | 0.014 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".