{"answer":{"query":"Toujeo","resolved_as":"applications","packages":8,"applications":["BLA206538"],"identity":{"application_numbers":["BLA206538"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2015-02-15","latest":"2023-04-01","packages_with_a_start_date":8}},"label_history":{"events_total":11,"non_cmc_events":7,"counts_by_class":{"LABELING":6,"EFFICACY":1},"cmc_events":4,"recent_non_cmc_events":[{"application":"BLA206538","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-29","documents":[{"type":"Label","date":"2024-08-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206538Orig1s017Lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-08-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206538Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"bd0b75f7a5cd66998d1c7c41"},{"application":"BLA206538","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-08-16","documents":[{"type":"Letter","date":"2022-08-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206538Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-08-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206538s016lbl.pdf","untrusted":true}}],"fact_id":"be5dc907edb6086b0e760f76"},{"application":"BLA206538","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-11-26","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206538Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-08-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s012lbl.pdf","untrusted":true}}],"fact_id":"55584bbafdec81e6d8234e46"},{"application":"BLA206538","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-15","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf","untrusted":true}}],"fact_id":"a2f8bd449f520e6bbb7d961f"},{"application":"BLA206538","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-15","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206538s013s014lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf","untrusted":true}}],"fact_id":"703351150a6154c87849e0d1"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"BLA206538","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TOUJEO SOLOSTAR","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"450 UNITS/1.5ML (300 UNITS/ML)","untrusted":true}},{"application":"BLA206538","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TOUJEO MAX SOLOSTAR","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"900 UNITS/3ML (300 UNITS/ML)","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Lilly Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.lillycares.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Sanofi Patient Connection","untrusted":true},"type":"manufacturer","url":"https://www.sanofipatientconnection.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Lilly Insulin Value Program","untrusted":true},"type":"manufacturer","url":"https://www.insulinaffordability.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Sanofi Insulin Valyou Savings Program","untrusted":true},"type":"manufacturer","url":"https://www.sanofipatientconnection.com/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Insulin Glargine,Hum.Rec.Anlog","untrusted":true},"brand":{"text":"Insulin Glargine","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":1131425.33,"claims":7964,"beneficiaries":4842,"average_spending_per_claim_usd":142.06746986,"fact_id":"3864f0dfd9f36a5b61003e0a"},{"year":2023,"gross_spending_usd":7523782.18,"claims":51328,"beneficiaries":26391,"average_spending_per_claim_usd":146.58241467,"fact_id":"b9b9ae5c53aaafbc50b12c1f"},{"year":2024,"gross_spending_usd":2703443.64,"claims":18156,"beneficiaries":10711,"average_spending_per_claim_usd":148.90083939,"fact_id":"4a04b58e31d883c1b36c5da3"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"biologic_status":{"products":[{"application":"BLA206538","status":"Reference","name":{"text":"Toujeo","untrusted":true},"proper_name":{"text":"insulin glargine","untrusted":true},"license_status":"Licensed","approval_date":"2015-02-25","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"01db2f5bdd6f9b1ac30dc910"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"medicaid_state_utilization":{"year":2025,"states_with_data":27,"all_states_medicaid_reimbursed_usd":4280430.28,"all_states_medicaid_paid_prescriptions":12808,"top_states":[{"state":"NY","medicaid_paid_prescriptions":2411,"medicaid_reimbursed_usd":745168.95,"total_reimbursed_usd":748853.64,"packages":2,"covers":"fee_for_service_only","fact_id":"30603699f7614d711eea1aa0"},{"state":"KY","medicaid_paid_prescriptions":1275,"medicaid_reimbursed_usd":473358.45,"total_reimbursed_usd":473358.45,"packages":2,"covers":"fee_for_service_only","fact_id":"3298f93549ff3cda8ed0a475"},{"state":"TX","medicaid_paid_prescriptions":1687,"medicaid_reimbursed_usd":396214.78,"total_reimbursed_usd":399450.89,"packages":2,"covers":"fee_for_service_only","fact_id":"3c1279ed229035d5cebf2f60"},{"state":"PA","medicaid_paid_prescriptions":794,"medicaid_reimbursed_usd":283717.28,"total_reimbursed_usd":283717.28,"packages":1,"covers":"fee_for_service_only","fact_id":"00f0fa1f8ce57cae6b6ad5f3"},{"state":"OR","medicaid_paid_prescriptions":806,"medicaid_reimbursed_usd":274252.1,"total_reimbursed_usd":274314.98,"packages":2,"covers":"fee_for_service_only","fact_id":"e03dab67af77896eb21cd800"},{"state":"NC","medicaid_paid_prescriptions":639,"medicaid_reimbursed_usd":258329.24,"total_reimbursed_usd":258839.13,"packages":2,"covers":"fee_for_service_only","fact_id":"677cf46089b21876ca760106"},{"state":"VT","medicaid_paid_prescriptions":160,"medicaid_reimbursed_usd":244514.25,"total_reimbursed_usd":246706.22,"packages":1,"covers":"all_record_types","fact_id":"dcddbb5aea79025f2d7c877a"},{"state":"IN","medicaid_paid_prescriptions":321,"medicaid_reimbursed_usd":186504.16,"total_reimbursed_usd":186504.16,"packages":2,"covers":"fee_for_service_only","fact_id":"31e17688bcff9b5b14b53ee7"},{"state":"MD","medicaid_paid_prescriptions":636,"medicaid_reimbursed_usd":154886.88,"total_reimbursed_usd":155609.88,"packages":2,"covers":"fee_for_service_only","fact_id":"c5663114094c44e6ef0d70ff"},{"state":"MI","medicaid_paid_prescriptions":269,"medicaid_reimbursed_usd":154149.19,"total_reimbursed_usd":154149.19,"packages":2,"covers":"fee_for_service_only","fact_id":"06d0ca2a439f1f0a8bd72029"}],"unlabelled_state_code_xx":null,"built_from_facts":47,"facts_fee_for_service_only":32,"older_year_facts_not_used":102,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"37a1788cffce5deeebf30122","field":"ndc.listing","entity":"ndc:00024586900"},{"fact_id":"bc75cb83b199a5b8275a9663","field":"ndc.listing","entity":"ndc:00024586903"},{"fact_id":"688f75ab41f75fe7c7b103af","field":"ndc.listing","entity":"ndc:00024587101"},{"fact_id":"bd0b75f7a5cd66998d1c7c41","field":"drug.label_event","entity":"application:BLA206538"},{"fact_id":"be5dc907edb6086b0e760f76","field":"drug.label_event","entity":"application:BLA206538"},{"fact_id":"55584bbafdec81e6d8234e46","field":"drug.label_event","entity":"application:BLA206538"},{"fact_id":"a2f8bd449f520e6bbb7d961f","field":"drug.label_event","entity":"application:BLA206538"},{"fact_id":"703351150a6154c87849e0d1","field":"drug.label_event","entity":"application:BLA206538"},{"fact_id":"a3ba4516ca4a908565e423e5","field":"drug.marketing_status","entity":"application:BLA206538"},{"fact_id":"28355f28a0e6f82f51ddee17","field":"drug.marketing_status","entity":"application:BLA206538"},{"fact_id":"3864f0dfd9f36a5b61003e0a","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|insulin-glargine"},{"fact_id":"b9b9ae5c53aaafbc50b12c1f","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|insulin-glargine"},{"fact_id":"4a04b58e31d883c1b36c5da3","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|insulin-glargine"},{"fact_id":"01db2f5bdd6f9b1ac30dc910","field":"drug.biologic_status","entity":"application:BLA206538"},{"fact_id":"30603699f7614d711eea1aa0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:NY"},{"fact_id":"3298f93549ff3cda8ed0a475","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:KY"},{"fact_id":"3c1279ed229035d5cebf2f60","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955390003:TX"},{"fact_id":"00f0fa1f8ce57cae6b6ad5f3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:PA"},{"fact_id":"e03dab67af77896eb21cd800","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:OR"},{"fact_id":"677cf46089b21876ca760106","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:NC"},{"fact_id":"dcddbb5aea79025f2d7c877a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024587102:VT"},{"fact_id":"31e17688bcff9b5b14b53ee7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:IN"},{"fact_id":"c5663114094c44e6ef0d70ff","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955390003:MD"},{"fact_id":"06d0ca2a439f1f0a8bd72029","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00955290002:MI"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:BLA206538","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}