{"id":"W2155591144","doi":"10.3390/ph5040353","title":"On the Regulatory Approval Pathway of Biosimilar Products","year":2012,"lang":"en","type":"article","venue":"Pharmaceuticals","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":113,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Harmonization; Innovator; Scope (computer science); Medicine; Drug approval; Product (mathematics); Business; Risk analysis (engineering); Pharmacology; Computer science; Finance; Drug","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01990276,0.000950221,0.0006559148,0.002355622,0.002069436,0.006493183,0.00153486,0.008129121,0.01233961],"category_scores_gemma":[0.02798063,0.0006419326,0.001472444,0.001327673,0.002756254,0.004579925,0.002163356,0.006981423,0.008460406],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003989418,"about_ca_system_score_gemma":0.01076986,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002269177,"about_ca_topic_score_gemma":0.002350585,"domain_scores_codex":[0.9724239,0.00848299,0.002427517,0.001582169,0.01371362,0.001369832],"domain_scores_gemma":[0.9838583,0.005140502,0.001791573,0.0008582275,0.007485444,0.000865983],"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":[0.0002944515,0.0002993658,0.00137542,0.001387678,0.00004579494,0.001860521,0.001314013,0.001137065,0.0107563,0.3171477,0.1708835,0.4934982],"study_design_scores_gemma":[0.0001206882,0.0003655239,0.001657844,0.001190772,0.00004331282,0.001679514,0.0002553168,0.0006337365,0.005408561,0.02175083,0.9668183,0.00007562828],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"review","genre_scores_codex":[0.02572937,0.08219516,0.08491676,0.1487272,0.008576329,0.003635257,0.001131634,0.002090664,0.6429975],"genre_scores_gemma":[0.3248302,0.1271528,0.1721748,0.1427765,0.008920583,0.002239194,0.002603283,0.001420354,0.2178823],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.01990276,"threshold_uncertainty_score":0.1052572,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0880573224176878,"score_gpt":0.3409084285292479,"score_spread":0.25285110611156,"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."}}