{"id":"W2759170843","doi":"10.2174/2213476x03666151221210747","title":"Regulatory Overview of Biosimilars: Current Scenario and Future Opportunities","year":2015,"lang":"en","type":"article","venue":"Applied Clinical Research Clinical Trials and Regulatory Affairs","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Biopharmaceutical; Medicine; Business; Risk analysis (engineering); Biotechnology","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":[0.01255167,0.001145212,0.001212271,0.002148316,0.001219718,0.007101863,0.002533199,0.01067877,0.01379228],"category_scores_gemma":[0.01521683,0.0005122774,0.001729661,0.00282733,0.002279904,0.009273878,0.002175267,0.008402117,0.004407062],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003803977,"about_ca_system_score_gemma":0.01296112,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002928593,"about_ca_topic_score_gemma":0.001849099,"domain_scores_codex":[0.9922658,0.001899383,0.0009541619,0.0009578831,0.003176849,0.0007460048],"domain_scores_gemma":[0.9860821,0.004749469,0.001898729,0.0003596708,0.005827745,0.001082255],"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":[0.0002384109,0.0001976985,0.0008689889,0.008830384,0.0000731927,0.0007948309,0.000443356,0.001260311,0.004907791,0.157156,0.2039669,0.6212621],"study_design_scores_gemma":[0.00002382178,0.000136594,0.0003957979,0.002852626,0.00004274263,0.0005982175,0.0001633804,0.0002946087,0.0007501594,0.01647202,0.9782413,0.00002867941],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.002588564,0.7696208,0.008802421,0.1335323,0.009209906,0.0002675405,0.0007976447,0.0003904008,0.07479043],"genre_scores_gemma":[0.02969773,0.8379836,0.01450193,0.08770169,0.009225492,0.0004548394,0.001786789,0.0001872337,0.01846075],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.01379228,"threshold_uncertainty_score":0.06638044,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.7556914656993441,"score_gpt":0.5835080839316263,"score_spread":0.1721833817677177,"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."}}