{"id":"W4400587065","doi":"10.52711/0974-360x.2024.00378","title":"A Systematic Review of Regulatory requirements of Biosimilar Products: WHO, India, European Union and USFDA","year":2024,"lang":"en","type":"review","venue":"Research Journal of Pharmacy and Technology","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Innovator; License; Biopharmaceutical; Product (mathematics); European union; Business; Interchangeability; Quality (philosophy); Medicine; Biotechnology; Risk analysis (engineering); Engineering; International trade; Finance; Computer science","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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01440384,0.000330324,0.003145687,0.00178522,0.00007862311,0.00001379591,0.0006941908,0.0003751544,0.00004930429],"category_scores_gemma":[0.002196666,0.0002025091,0.0002802562,0.001538358,0.001587002,0.00008103061,0.0006229568,0.002053154,0.000008391779],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00005594327,"about_ca_system_score_gemma":0.0003505442,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00000198599,"about_ca_topic_score_gemma":1.41499e-7,"domain_scores_codex":[0.9920616,0.004776864,0.002157787,0.0003799656,0.0002200941,0.0004037399],"domain_scores_gemma":[0.996887,0.000414166,0.001348204,0.0004611253,0.0008270944,0.00006237158],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"systematic_review","study_design_gemma":"systematic_review","study_design_scores_codex":[0.00001383825,0.00009006576,0.000005290701,0.8339344,0.001500079,0.00007370497,0.00001461254,5.089764e-10,0.001680552,0.0005752525,0.003242626,0.1588696],"study_design_scores_gemma":[0.0003304716,0.0004525613,8.4188e-7,0.6244889,0.003676098,0.001329179,0.00003470284,1.779024e-7,0.003343923,0.0002482593,0.3659425,0.0001523604],"study_design_candidate":"systematic_review","study_design_consensus":"systematic_review","genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.00005577925,0.9974749,0.000005071019,0.001015992,0.000194206,0.001004876,0.00005724061,0.00001338898,0.0001785653],"genre_scores_gemma":[0.0004845877,0.9989295,0.0001458856,0.00003084223,0.00004025907,0.00001166486,0.000005066594,0.0000346594,0.0003175153],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.3626999,"threshold_uncertainty_score":0.8920048,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1190203360858051,"score_gpt":0.4601811171710643,"score_spread":0.3411607810852592,"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."}}