Biosimilars and Reference Biologics: Decisions on Biosimilar Interchangeability Require the Involvement of Dermatologists Biosimilares y biológicos de referencia: la intercambiabilidad de los biosimilares requiere la participación del dermatólogo
Bibliographic record
Abstract
On September 13, 2013, the European Medicines Agency (EMA) approved the first biosimilar and treatment of moderate to severe psoriasis will be one of the indications. Undoubtedly this important news for dermatologists will have a major impact on prescribing patterns and management of patients with moderate to severe psoriasis. On June 27, 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended that the EMA approve Inflectra (the applicant was Hospira UK) and Remsima (the applicant was Celltrion Healthcare Hungary Kft).These biosimilars (CT-P13, Remsima) have already been approved in South Korea. The 2 manufacturers (Celltrion and Hospira) have reached an agreement to market 8 biosimilars in the United States, Europe, Canada, Australia, and New Zealand. The active substance in both cases is infliximab, and both are biological medicinal products, similar to the reference product Remicade (infliximab), approved in the European Union since August 13, 1999. Published studies suggest that both products have a quality, safety, and efficacy profile similar to Remicade (infliximab). Thus the clinical trials PLANETRA and PLANETAS were able to show comparable efficacy to the innovator reference product infliximab in the treatment of
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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 | 0.214 | 0.354 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.006 | 0.020 |
| Scholarly communication | 0.019 | 0.022 |
| Open science | 0.006 | 0.008 |
| Research integrity | 0.056 | 0.038 |
| Insufficient payload (model declined to judge) | 0.007 | 0.007 |
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".