{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0489233,0.001513668,0.003037672,0.009625749,0.001577756,0.01090495,0.003854986,0.009017334,0.003294277],"category_scores_gemma":[0.07420981,0.001284749,0.003441785,0.01666139,0.003939443,0.01179438,0.006090564,0.009545982,0.00196197],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.008100551,"about_ca_system_score_gemma":0.02316786,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007893059,"about_ca_topic_score_gemma":0.009093695,"domain_scores_codex":[0.9576741,0.00926196,0.01435337,0.002156211,0.01482908,0.001725217],"domain_scores_gemma":[0.8724504,0.05095788,0.03252075,0.002505206,0.03571817,0.005847598],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.0002593757,0.000134295,0.004473119,0.01112909,0.0002887658,0.0009896031,0.001450117,0.0008762888,0.0008770006,0.005599606,0.2308457,0.7430771],"study_design_scores_gemma":[0.00003715734,0.00009242188,0.003926449,0.01078814,0.0002389476,0.001508604,0.0007704461,0.000110788,0.0004769769,0.0009485723,0.9810387,0.00006278263],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.004898017,0.8512506,0.002569072,0.1206901,0.006994657,0.0001412148,0.001236697,0.0003268919,0.01189263],"genre_scores_gemma":[0.02481902,0.8704098,0.008765201,0.08471354,0.004956414,0.0002803697,0.002893445,0.0002704457,0.002891859],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.0489233,"threshold_uncertainty_score":0.2587342,"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."}}