Bibliographic record
Abstract
BACKGROUND: Biosimilars provide opportunities for improving healthcare access and outcomes and reducing overall healthcare costs for patients with cancer. OBJECTIVES: The purpose of this article is to explore the history of biosimilars, regulatory pathways, and barriers to biosimilar approval. This article also aims to describe the patient and clinician barriers to biosimilars use and the progress that has been achieved since the first biosimilar approval in Europe in 2006 and in the United States in 2015. METHODS: A literature search was conducted to retrieve articles that are highly relevant to the history of biosimilars development and regulatory pathways in the United States, Europe, Asia, and Canada. Patient and clinician perspectives on safety issues and concerns regarding immunogenicity and bioequivalence that limit use of biosimilars are also included. FINDINGS: Patient and provider concerns regarding immunologic patient safety issues, such as immunogenicity, lack of comparability, and low biosimilarity, still exist. The clinical safety, efficacy, and tolerability of biosimilars are among the top concerns in patients, prescribers, and clinicians.
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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.019 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".