{"answer":{"query":"Simponi","resolved_as":"applications","packages":8,"applications":["BLA125289"],"identity":{"application_numbers":["BLA125289"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2009-04-25","latest":"2013-05-15","packages_with_a_start_date":8}},"label_history":{"events_total":32,"non_cmc_events":32,"counts_by_class":{"LABELING":26,"EFFICACY":6},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA125289","submission_no":158,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-22","documents":[{"type":"Letter","date":"2025-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125289Orig1s158ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-10-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125289s158lbl.pdf","untrusted":true}}],"fact_id":"5827b9b47f9c7cdb75bb9e96"},{"application":"BLA125289","submission_no":157,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-10-07","documents":[{"type":"Label","date":"2025-10-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125289s157lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125289Orig1s157ltr.pdf","untrusted":true}}],"fact_id":"22f87fcc6951ae222322f1e4"},{"application":"BLA125289","submission_no":156,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-01","documents":[{"type":"Label","date":"2025-10-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125289s156lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125289Orig1s156ltr.pdf","untrusted":true}}],"fact_id":"8d3a2f1504493bd035fdc77d"},{"application":"BLA125289","submission_no":155,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-04-18","documents":[{"type":"Label","date":"2025-04-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125289Orig1s155,125433Orig1s036Correctedlbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-07-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125289Orig1s155,125433Orig1s036Correctedltr.pdf","untrusted":true}}],"fact_id":"e36b14624242082eff239b6c"},{"application":"BLA125289","submission_no":153,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-16","documents":[{"type":"Letter","date":"2023-11-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125289Orig1s153ltr.pdf","untrusted":true}}],"fact_id":"6716bbb754bf8d53279cc381"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"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":"BLA125289","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SIMPONI","untrusted":true},"form":{"text":"INJECTABLE; INJECTION","untrusted":true},"strength":{"text":"50MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Golimumab","untrusted":true},"brand":{"text":"Simponi","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":137537141.03,"claims":21022,"beneficiaries":3087,"average_spending_per_claim_usd":6542.5335853,"fact_id":"c4469a99a2a659fd1e5a65b1"},{"year":2021,"gross_spending_usd":145806383.61,"claims":22053,"beneficiaries":3202,"average_spending_per_claim_usd":6611.6348619,"fact_id":"8ea9a00db41d595c696a4a41"},{"year":2022,"gross_spending_usd":162839049.87,"claims":23373,"beneficiaries":3360,"average_spending_per_claim_usd":6966.9725696,"fact_id":"4362c3e9540d084f1aa801a6"},{"year":2023,"gross_spending_usd":177180473.48,"claims":24618,"beneficiaries":3463,"average_spending_per_claim_usd":7197.1920335,"fact_id":"64ad89fed61a4cd044ad85f5"},{"year":2024,"gross_spending_usd":184712560.18,"claims":25616,"beneficiaries":3667,"average_spending_per_claim_usd":7210.8276148,"fact_id":"48cee3ce7cc961c465c03154"}],"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":"BLA125289","status":"Reference","name":{"text":"Simponi","untrusted":true},"proper_name":{"text":"golimumab","untrusted":true},"license_status":"Licensed","approval_date":"2009-04-24","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":1,"biosimilars":[],"interchangeables":[{"name":{"text":"Immgolis; Immgolis Intri","untrusted":true},"proper_name":{"text":"golimumab-sldi","untrusted":true},"bla_number":"761452","approval_date":"2026-05-15","interchangeable_date":"2026-05-15"}],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"1f9a71ed1ad7e1e311a5b1d2"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"rems":{"programs":[{"application":"BLA125289","program":{"text":"Simponi","untrusted":true},"rems_id":"266","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2009-04-24","last_modified":"2011-03-17","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=266","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"357fc43b777726dfd31bd641"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"golimumab","untrusted":true},"designation_count":4,"approved_count":2,"recent":[{"designated":"2015-04-02","use":{"text":"Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age.","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":true},{"designated":"2012-05-21","use":{"text":"Treatment of sarcoidosis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Biotech, Inc.","untrusted":true},"approved":false},{"designated":"2012-03-16","use":{"text":"Treatment of pediatric ulcerative colitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Janssen Biotech, Inc.","untrusted":true},"approved":true},{"designated":"2004-11-02","use":{"text":"Treatment of chronic sarcoidosis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Centocor, Inc.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"3c8dcf34fc97536a97462742"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":2,"all_states_medicaid_reimbursed_usd":990468.79,"all_states_medicaid_paid_prescriptions":199,"top_states":[{"state":"KY","medicaid_paid_prescriptions":140,"medicaid_reimbursed_usd":626462.46,"total_reimbursed_usd":626462.46,"packages":1,"covers":"fee_for_service_only","fact_id":"ecbdb311938e88fc7b0f998f"},{"state":"ND","medicaid_paid_prescriptions":59,"medicaid_reimbursed_usd":364006.33,"total_reimbursed_usd":364006.33,"packages":1,"covers":"all_record_types","fact_id":"f3e6791ab054b21a55ce37e9"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":1,"older_year_facts_not_used":39,"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":"063ce7757bdb758b52d17490","field":"ndc.listing","entity":"ndc:57894007001"},{"fact_id":"18d16f09ee993009135ad167","field":"ndc.listing","entity":"ndc:57894007002"},{"fact_id":"18a35861cf72937bb58fad2c","field":"ndc.listing","entity":"ndc:57894007089"},{"fact_id":"5827b9b47f9c7cdb75bb9e96","field":"drug.label_event","entity":"application:BLA125289"},{"fact_id":"22f87fcc6951ae222322f1e4","field":"drug.label_event","entity":"application:BLA125289"},{"fact_id":"8d3a2f1504493bd035fdc77d","field":"drug.label_event","entity":"application:BLA125289"},{"fact_id":"e36b14624242082eff239b6c","field":"drug.label_event","entity":"application:BLA125289"},{"fact_id":"6716bbb754bf8d53279cc381","field":"drug.label_event","entity":"application:BLA125289"},{"fact_id":"3ea0d122e1d193c94a7408c7","field":"drug.marketing_status","entity":"application:BLA125289"},{"fact_id":"c4469a99a2a659fd1e5a65b1","field":"drug.partd_spending","entity":"drug:golimumab|simponi"},{"fact_id":"8ea9a00db41d595c696a4a41","field":"drug.partd_spending","entity":"drug:golimumab|simponi"},{"fact_id":"4362c3e9540d084f1aa801a6","field":"drug.partd_spending","entity":"drug:golimumab|simponi"},{"fact_id":"64ad89fed61a4cd044ad85f5","field":"drug.partd_spending","entity":"drug:golimumab|simponi"},{"fact_id":"48cee3ce7cc961c465c03154","field":"drug.partd_spending","entity":"drug:golimumab|simponi"},{"fact_id":"1f9a71ed1ad7e1e311a5b1d2","field":"drug.biologic_status","entity":"application:BLA125289"},{"fact_id":"5eb5e3fed3b5d24f2c9555f4","field":"drug.biologic_status","entity":"application:BLA761452"},{"fact_id":"357fc43b777726dfd31bd641","field":"drug.rems","entity":"application:BLA125289"},{"fact_id":"3c8dcf34fc97536a97462742","field":"drug.orphan_designation","entity":"drug:golimumab"},{"fact_id":"ecbdb311938e88fc7b0f998f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894007002:KY"},{"fact_id":"f3e6791ab054b21a55ce37e9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:57894007002:ND"}],"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:BLA125289","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":"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":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient 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."}