{"id":"W3013519416","doi":"10.1016/j.biologicals.2020.02.005","title":"The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019","year":2020,"lang":"en","type":"review","venue":"Biologicals","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":63,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Ministry of Health and Welfare; World Health Organization","keywords":"Biosimilar; Business; Terminology; Competition (biology); Quality (philosophy); Risk analysis (engineering); Medicine","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":[0.00480894,0.0006431359,0.0008358167,0.002230971,0.0003661139,0.001838068,0.001018498,0.001889148,0.002487655],"category_scores_gemma":[0.005540926,0.000277095,0.0008004336,0.003068833,0.0009888334,0.00238082,0.001074116,0.002465143,0.0009516857],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002695278,"about_ca_system_score_gemma":0.00790058,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00447527,"about_ca_topic_score_gemma":0.00367568,"domain_scores_codex":[0.998192,0.0004471529,0.0002636377,0.0001912253,0.000725476,0.0001804263],"domain_scores_gemma":[0.9971064,0.00124634,0.0004875546,0.00005824073,0.0009582399,0.0001432109],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0001063714,0.00004201952,0.0002417268,0.01704047,0.00005023096,0.0001811312,0.0002300545,0.0004166027,0.001022839,0.0191124,0.04690384,0.9146523],"study_design_scores_gemma":[0.0000106974,0.00005066991,0.0005841426,0.006470424,0.00006029499,0.0003249234,0.0000885609,0.00006117848,0.0004467889,0.001811179,0.9900803,0.00001088677],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0001911273,0.9930998,0.0001772936,0.003551498,0.0003769081,0.000008738413,0.00004074203,0.00001149684,0.002542406],"genre_scores_gemma":[0.002223401,0.9939986,0.0003440407,0.002272141,0.0003180807,0.00001375714,0.0000716237,0.000005426879,0.0007529526],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.00480894,"threshold_uncertainty_score":0.02543247,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04131380638215703,"score_gpt":0.3328274907636161,"score_spread":0.291513684381459,"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."}}