{"id":"W3107373271","doi":"10.1111/nyas.14522","title":"Regulatory challenges with biosimilars: an update from 20 countries","year":2020,"lang":"en","type":"article","venue":"Annals of the New York Academy of Sciences","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":49,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"World Health Organization","keywords":"Biosimilar; Interchangeability; Pharmacovigilance; Business; Risk analysis (engineering); Regulatory science; Quality (philosophy); Medicine; Pharmacology; Computer science; Adverse effect","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0006250842,0.0001474224,0.0003454646,0.00003921675,0.0001532891,0.00001192043,0.001048361,0.0002371645,0.0002056107],"category_scores_gemma":[0.00007930113,0.00007852552,0.00009519306,0.0002965592,0.002475854,0.0001598206,0.0001341834,0.0002380526,0.000009987978],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000001891708,"about_ca_system_score_gemma":0.00007564223,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00002658322,"about_ca_topic_score_gemma":0.000007325593,"domain_scores_codex":[0.998732,0.0002149439,0.0002952676,0.0003516141,0.0001426931,0.0002635113],"domain_scores_gemma":[0.9993118,0.0001806995,0.0002783614,0.0001280265,0.00003613599,0.00006499401],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.001614647,0.0003181914,0.008946016,0.0001629156,0.001078015,0.000001061527,0.005006857,0.0000979919,0.5166753,0.06191643,0.3503192,0.05386343],"study_design_scores_gemma":[0.0002866831,0.0004879368,0.01106719,0.0001174049,0.00006052573,0.000002233045,0.0005405986,0.00001523186,0.8340316,0.009573589,0.1436574,0.0001596658],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.3119752,0.06625248,0.00003034927,0.620095,0.0001860783,0.0002220448,0.0001387193,0.00004728068,0.001052867],"genre_scores_gemma":[0.9763865,0.002403859,0.0017426,0.01922191,0.00009151476,0.00000112372,0.000001300287,0.000007307974,0.0001439052],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.6644113,"threshold_uncertainty_score":0.9122388,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1402271942238271,"score_gpt":0.3386055666856391,"score_spread":0.198378372461812,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}