{"answer":{"query":"Kevzara","resolved_as":"applications","packages":8,"applications":["BLA761037"],"identity":{"application_numbers":["BLA761037"],"marketing_categories":["BLA"],"labelers":[{"text":"SANOFI-AVENTIS, US LLC","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2017-05-22","latest":"2018-04-13","packages_with_a_start_date":8}},"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"EFFICACY":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761037","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-06-10","documents":[{"type":"Letter","date":"2024-06-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761037Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-06-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761037s015lbl.pdf","untrusted":true}}],"fact_id":"8e72dc18c173c11314e1bb27"},{"application":"BLA761037","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-02-28","documents":[{"type":"Letter","date":"2023-03-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761037Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf","untrusted":true}}],"fact_id":"6632fe19a20133fcad262b1e"},{"application":"BLA761037","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2018-04-13","documents":[{"type":"Label","date":"2018-04-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-04-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761037Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"7d30e5f11a794c008d42c906"}],"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":"BLA761037","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KEVZARA","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"200MG/1.14ML","untrusted":true}},{"application":"BLA761037","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KEVZARA","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"150MG/1.14ML","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2027-04-30"],"packages_with_future_termination_date":1,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Sarilumab","untrusted":true},"brand":{"text":"Kevzara","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":54152208.01,"claims":14066,"beneficiaries":2219,"average_spending_per_claim_usd":3849.865492,"fact_id":"25430bfba5cc4e81064c6b72"},{"year":2021,"gross_spending_usd":61125619.95,"claims":14954,"beneficiaries":2535,"average_spending_per_claim_usd":4087.5765648,"fact_id":"9f24b62f8b3524556fa55005"},{"year":2022,"gross_spending_usd":80837227.23,"claims":18579,"beneficiaries":2969,"average_spending_per_claim_usd":4350.9999047,"fact_id":"6f3a139494bbfd654b6b1157"},{"year":2023,"gross_spending_usd":110312727.61,"claims":24099,"beneficiaries":4167,"average_spending_per_claim_usd":4577.4815391,"fact_id":"511dff90cff1b4e659432669"},{"year":2024,"gross_spending_usd":172196863.69,"claims":37496,"beneficiaries":6254,"average_spending_per_claim_usd":4592.4062217,"fact_id":"d6c220ddc0ddf174b9c1b858"}],"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":"BLA761037","status":"Reference","name":{"text":"Kevzara","untrusted":true},"proper_name":{"text":"sarilumab","untrusted":true},"license_status":"Licensed","approval_date":"2017-05-22","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":"bd0a2b32dc1974359225008e"}],"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":3,"all_states_medicaid_reimbursed_usd":780223.5,"all_states_medicaid_paid_prescriptions":174,"top_states":[{"state":"IA","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":275279.88,"total_reimbursed_usd":275279.88,"packages":1,"covers":"all_record_types","fact_id":"c0842071a143edb830f53b6b"},{"state":"NH","medicaid_paid_prescriptions":57,"medicaid_reimbursed_usd":260691.75,"total_reimbursed_usd":260691.75,"packages":1,"covers":"all_record_types","fact_id":"941bb325fd0ce79375c9f39f"},{"state":"MA","medicaid_paid_prescriptions":55,"medicaid_reimbursed_usd":244251.87,"total_reimbursed_usd":244251.87,"packages":1,"covers":"fee_for_service_only","fact_id":"d66829c603d5bdd64a29cc05"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":1,"older_year_facts_not_used":33,"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":"4b1805403523df8c9ad16f69","field":"ndc.listing","entity":"ndc:00024590801"},{"fact_id":"d558ea2ee9df39a24f6b291c","field":"ndc.listing","entity":"ndc:00024590802"},{"fact_id":"5a8d68ed22df507938833af7","field":"ndc.listing","entity":"ndc:00024591001"},{"fact_id":"8e72dc18c173c11314e1bb27","field":"drug.label_event","entity":"application:BLA761037"},{"fact_id":"6632fe19a20133fcad262b1e","field":"drug.label_event","entity":"application:BLA761037"},{"fact_id":"7d30e5f11a794c008d42c906","field":"drug.label_event","entity":"application:BLA761037"},{"fact_id":"b3c2bae997aa87976618ce3b","field":"drug.marketing_status","entity":"application:BLA761037"},{"fact_id":"8005577585a3eae6b343ca2a","field":"drug.marketing_status","entity":"application:BLA761037"},{"fact_id":"39a03706e1d4ecdc0fb2dda5","field":"ndc.product","entity":"ndc:00024590801"},{"fact_id":"25430bfba5cc4e81064c6b72","field":"drug.partd_spending","entity":"drug:sarilumab|kevzara"},{"fact_id":"9f24b62f8b3524556fa55005","field":"drug.partd_spending","entity":"drug:sarilumab|kevzara"},{"fact_id":"6f3a139494bbfd654b6b1157","field":"drug.partd_spending","entity":"drug:sarilumab|kevzara"},{"fact_id":"511dff90cff1b4e659432669","field":"drug.partd_spending","entity":"drug:sarilumab|kevzara"},{"fact_id":"d6c220ddc0ddf174b9c1b858","field":"drug.partd_spending","entity":"drug:sarilumab|kevzara"},{"fact_id":"bd0a2b32dc1974359225008e","field":"drug.biologic_status","entity":"application:BLA761037"},{"fact_id":"c0842071a143edb830f53b6b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024592201:IA"},{"fact_id":"941bb325fd0ce79375c9f39f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024592201:NH"},{"fact_id":"d66829c603d5bdd64a29cc05","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024592201:MA"}],"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:BLA761037","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":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"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."}