{"answer":{"query":"Humira","resolved_as":"applications","packages":23,"applications":["BLA125057"],"identity":{"application_numbers":["BLA125057"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2002-12-31","latest":"2024-02-14","packages_with_a_start_date":23}},"label_history":{"events_total":60,"non_cmc_events":55,"counts_by_class":{"LABELING":30,"EFFICACY":24,"S":1},"cmc_events":5,"recent_non_cmc_events":[{"application":"BLA125057","submission_no":425,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-12-23","documents":[{"type":"Letter","date":"2025-12-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125057Orig1s425ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-01-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125057s425lbl.pdf","untrusted":true}}],"fact_id":"353ddfff817e9a1ad9ca75e0"},{"application":"BLA125057","submission_no":424,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-07-16","documents":[{"type":"Letter","date":"2025-07-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125057Orig1s424ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-07-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125057s424lbl.pdf","untrusted":true}}],"fact_id":"046a929615913ff645c4f613"},{"application":"BLA125057","submission_no":423,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-03","documents":[{"type":"Letter","date":"2023-11-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125057Orig1s423ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-11-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125057s423lbl.pdf","untrusted":true}}],"fact_id":"ec305a37318019ec29553e81"},{"application":"BLA125057","submission_no":417,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-02-24","documents":[{"type":"Letter","date":"2021-02-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125057Orig1s417ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-02-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf","untrusted":true}}],"fact_id":"6a7d09431ce7c051beb2a1fa"},{"application":"BLA125057","submission_no":419,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-12-16","documents":[{"type":"Letter","date":"2020-12-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s418, s419ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-12-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf","untrusted":true}}],"fact_id":"5242a370a5c0daf8ae42fb3c"}],"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":"BLA125057","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"HUMIRA","untrusted":true},"form":{"text":"VIAL","untrusted":true},"strength":{"text":"40MG/0.8ML","untrusted":true}},{"application":"BLA125057","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"HUMIRA","untrusted":true},"form":{"text":"SYRINGE","untrusted":true},"strength":{"text":"40MG/0.8ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":23,"most_recent":[{"recall_number":"D-0734-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"2b04bd580d7f2e0c71933425"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"myAbbVie Assist","untrusted":true},"type":"manufacturer","url":"https://www.abbvie.com/patients/patient-assistance.html","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"AbbVie Humira Complete Savings Card","untrusted":true},"type":"manufacturer","url":"https://www.humira.com/humira-complete/cost-and-copay","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"HealthWell Foundation","untrusted":true},"type":"nonprofit","url":"https://www.healthwellfoundation.org/","status":{"state":"limited","effective":null,"applies_to":{"text":"HealthWell Foundation disease funds, as listed on the homepage when read","untrusted":true},"detail":{"text":"The HealthWell Foundation homepage lists disease funds as Open or Closed when read. Closed funds include Type 2 Diabetes, Migraine and Multiple Sclerosis - Medicare Access; open funds include Multiple Myeloma - Medicare Access, which the page says offers up to $8,000 in prescription drug copayment or Medicare Part B premium assistance. The page carries no fund-level date; the status is as of the read.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.healthwellfoundation.org/","proof_state":"verified"},"needs_status_check":true,"has_offer":false},{"name":{"text":"Good Days (formerly Chronic Disease Fund)","untrusted":true},"type":"nonprofit","url":"https://www.mygooddays.org/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"TAF Cares (The Assistance Fund)","untrusted":true},"type":"nonprofit","url":"https://tafcares.org/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[{"program":"humira-complete-savings-card","kind":"copay_card","price_figures":{"payAsLittleAsPerMonth":0,"maxAnnualBenefit":14000},"conditions":{"text":"The page states the card is for commercially insured patients, is not available to patients receiving government-funded coverage, and offers a Prescription Rebate route if a pharmacy cannot process the card; the maximum annual benefit is per calendar year, and the page states the offer is subject to change or discontinuance without notice.","untrusted":true},"limited_time":false,"expires_note":null,"stated_end_date":null,"expired":false,"detail":{"text":"The Humira Complete page states a Savings Card for commercially insured patients with a cost as little as $0 per month, subject to a maximum annual benefit of $14,000 per calendar year. No end date is stated.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.humira.com/humira-complete/cost-and-copay","proof_state":"verified","fact_id":"15b4f10dfad7b288c9ff5a85"}],"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":"Adalimumab","untrusted":true},"brand":{"text":"Humira","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":383631561.95,"claims":54896,"beneficiaries":8312,"average_spending_per_claim_usd":6988.3336117,"fact_id":"b367dbde15a283ea93843f3a"},{"year":2021,"gross_spending_usd":328556268.43,"claims":44560,"beneficiaries":6530,"average_spending_per_claim_usd":7373.3453418,"fact_id":"12a8323fe0d124758c04d415"},{"year":2022,"gross_spending_usd":298038023.37,"claims":38494,"beneficiaries":5598,"average_spending_per_claim_usd":7742.4539765,"fact_id":"5a5b3fa4e06f0381d94a5f2a"},{"year":2023,"gross_spending_usd":257644313.48,"claims":30607,"beneficiaries":4742,"average_spending_per_claim_usd":8417.8231607,"fact_id":"d12b84b90829217e5d5dcdc0"},{"year":2024,"gross_spending_usd":208905154.75,"claims":25521,"beneficiaries":3912,"average_spending_per_claim_usd":8185.6179127,"fact_id":"0acfe967f2bdcb5bb2bcbadd"}],"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; 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it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"adalimumab","untrusted":true},"designation_count":10,"approved_count":8,"recent":[{"designated":"2025-03-13","use":{"text":"treatment of Takayasu arteritis","untrusted":true},"status":"Designated","sponsor":{"text":"ODDIFACT SAS","untrusted":true},"approved":false},{"designated":"2015-05-13","use":{"text":"Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"AbbVie, Inc.","untrusted":true},"approved":true},{"designated":"2015-05-13","use":{"text":"Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"AbbVie, Inc.","untrusted":true},"approved":true},{"designated":"2014-07-10","use":{"text":"Treatment of Behcet's disease","untrusted":true},"status":"Designated","sponsor":{"text":"Mucora","untrusted":true},"approved":false},{"designated":"2014-05-13","use":{"text":"Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"AbbVie, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"6b8a9ff85e6e6752e8bbd32e"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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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:BLA125057","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":"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":"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."}