Bibliographic record
Abstract
D the burgeoning biosimilars industry is the lucrative biologics market, worth billions, with multiple patents expiring or set to expire soon. Historically, European and Canadian regulatory authorities have taken global leadership roles in biosimilars drug development. For example, EMA published test procedures and acceptance criteria for biological products in 1999. Europe leads the pack with the most advanced and detailed biosimilar regulatory guidance spearheading a “totality of evidence” approach and has granted the most approvals. Other countries are moving ahead rapidly to provide cheaper copies of biologics to their citizens. The US has made significant advances towards issuing draft guidance, though it still appears that near-term, approvals will be made on a caseby-case basis. Commensurate with limited guidance and extensive innovator lobbying, the FDA has granted only one biosimilars approval – a less complex protein (filgrastim-sndz or “Zarxio” from Novartis) in March, 2015 under the 351(k) registration pathway approved under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Further hampering progress towards US approval of a monoclonal antibody biosimilar, an FDA Advisory Committee meeting on a Remicade biosimilar from Celltrion was recently delayed. CDER recently announced that four additional biosimilar documents are set to be published in 2015. This presentation will describe the evolution of biosimilar development over the last 15 years, discussing key milestones leading to the first approvals in various markets. Outstanding issues will also be addressed relating to the race to identify and obtain the patients needed for global biosimilar registration trials.
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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".