Biosimilar Substitution Policies: An Overview
Bibliographic record
Abstract
Substitution has been implemented for generics in most markets and very often resulted in high uptake correlated with fast and strong price erosion. Although biosimilars and generics are different, the low biosimilar penetration in most of Europe prompted some countries to discuss the implementation of substitution for biosimilars as an initiative to quickly reduce healthcare spending by boosting their uptake. The objective of this study was to identify initiatives undertaken worldwide with regards to biosimilar substitution and their potential implications. A literature review was conducted from European and national health authorities’ websites, Generics and Biosimilars Initiative website, Medline® database, and available grey literature. In Europe, European Medicines Agency leaves substitution responsibility to national regulators. Sixteen EU Member States have either law or guidelines prohibiting automatic biosimilar substitution. In 2013, France became the first European country to pass a law for biosimilar substitution. In 2014, Norwegian government set up a clinical study to assess interchangeability of Remicade® (infliximab) and its biosimilar. In the United-States, the Food and Drug Administration has the authority to designate a biosimilar as interchangeable but substitution is then regulated at state level. Thirty one states have currently considered legislation establishing standards for biosimilar substitution. In Canada, interchangeability remains a provincial decision. So far, one province positioned against substitution. The Pharmaceutical Benefits Advisory Committee in Australia recently considered marking biosimilar as equivalent to reference product, which would allow substitution at pharmacy level. In South Korea, Japan and South Africa automatic substitution is prohibited at pharmacy level. In most countries, the choice of treatment with a reference biologic or with a biosimilar remains a clinical decision entrusted to the prescribing physician. Enhancing substitution may increase the penetration of biosimilars which constitutes an additional therapeutic option available to practitioners.
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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 | 0.006 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.012 | 0.017 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.006 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.002 |
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".