{"answer":{"query":"Betaseron","resolved_as":"applications","packages":4,"applications":["BLA103471"],"identity":{"application_numbers":["BLA103471"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2009-08-11","latest":"2016-09-01","packages_with_a_start_date":4}},"label_history":{"events_total":39,"non_cmc_events":37,"counts_by_class":{"LABELING":20,"EFFICACY":4,"S":13},"cmc_events":2,"recent_non_cmc_events":[{"application":"BLA103471","submission_no":5203,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-05-09","documents":[{"type":"Letter","date":"2024-05-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103471Orig1s5203ltr.pdf","untrusted":true}}],"fact_id":"d03c121830304fbedab6f590"},{"application":"BLA103471","submission_no":5202,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-07-28","documents":[{"type":"Label","date":"2023-07-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103471s5202lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-07-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103471Orig1s5202ltr.pdf","untrusted":true}}],"fact_id":"4adc1f28582d7eee38518db8"},{"application":"BLA103471","submission_no":5201,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-09-02","documents":[{"type":"Letter","date":"2022-09-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103471Orig1s5201ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-09-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103471s5201lbl.pdf","untrusted":true}}],"fact_id":"25592d3751eafe505924377e"},{"application":"BLA103471","submission_no":5200,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-11-03","documents":[{"type":"Letter","date":"2021-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103471Orig1s5200ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-11-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103471s5200lbl.pdf","untrusted":true}}],"fact_id":"1e389a37c4e329c9261b06b0"},{"application":"BLA103471","submission_no":5197,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-10-01","documents":[{"type":"Letter","date":"2020-10-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103471Orig1s5197ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-10-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103471s5197lbl.pdf","untrusted":true}}],"fact_id":"76a34e6a61a692059b696d8b"}],"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":"BLA103471","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BETASERON","untrusted":true},"form":{"text":"VIAL; SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.3 MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Interferon Beta-1b","untrusted":true},"brand":{"text":"Betaseron","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":163581520.93,"claims":18758,"beneficiaries":2113,"average_spending_per_claim_usd":8720.6269821,"fact_id":"0eefcc4848bf4fdaded027fc"},{"year":2021,"gross_spending_usd":130156656.84,"claims":14920,"beneficiaries":1702,"average_spending_per_claim_usd":8723.6365174,"fact_id":"6aec9deee9ccbedf7729d879"},{"year":2022,"gross_spending_usd":118527291.06,"claims":12830,"beneficiaries":1492,"average_spending_per_claim_usd":9238.2923663,"fact_id":"406fd5c0d249448b0cdd9748"},{"year":2023,"gross_spending_usd":103287435.69,"claims":10466,"beneficiaries":1207,"average_spending_per_claim_usd":9868.8549293,"fact_id":"35f139b937fb982d701c5990"},{"year":2024,"gross_spending_usd":92238675.09,"claims":9136,"beneficiaries":1042,"average_spending_per_claim_usd":10096.177221,"fact_id":"f658b1c6606894b84d644a8b"}],"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":"BLA103471","status":"Reference","name":{"text":"Betaseron","untrusted":true},"proper_name":{"text":"interferon beta-1b","untrusted":true},"license_status":"Licensed","approval_date":"1993-07-23","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":"ed6eb411549ee00199da665b"}],"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":1,"all_states_medicaid_reimbursed_usd":590323.55,"all_states_medicaid_paid_prescriptions":61,"top_states":[{"state":"PA","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":590323.55,"total_reimbursed_usd":590323.55,"packages":1,"covers":"all_record_types","fact_id":"a4a842e809a83b3d77e0c522"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":9,"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":"ef1f2304916b8c3dd7bb2542","field":"ndc.listing","entity":"ndc:50419052405"},{"fact_id":"18f9330ddbf8bc381dad31b9","field":"ndc.listing","entity":"ndc:50419052409"},{"fact_id":"25948f957533da6e90cb9d99","field":"ndc.listing","entity":"ndc:50419052435"},{"fact_id":"d03c121830304fbedab6f590","field":"drug.label_event","entity":"application:BLA103471"},{"fact_id":"4adc1f28582d7eee38518db8","field":"drug.label_event","entity":"application:BLA103471"},{"fact_id":"25592d3751eafe505924377e","field":"drug.label_event","entity":"application:BLA103471"},{"fact_id":"1e389a37c4e329c9261b06b0","field":"drug.label_event","entity":"application:BLA103471"},{"fact_id":"76a34e6a61a692059b696d8b","field":"drug.label_event","entity":"application:BLA103471"},{"fact_id":"c2ca6eacd8db5b2aa6ea080c","field":"drug.marketing_status","entity":"application:BLA103471"},{"fact_id":"0eefcc4848bf4fdaded027fc","field":"drug.partd_spending","entity":"drug:interferon-beta-1b|betaseron"},{"fact_id":"6aec9deee9ccbedf7729d879","field":"drug.partd_spending","entity":"drug:interferon-beta-1b|betaseron"},{"fact_id":"406fd5c0d249448b0cdd9748","field":"drug.partd_spending","entity":"drug:interferon-beta-1b|betaseron"},{"fact_id":"35f139b937fb982d701c5990","field":"drug.partd_spending","entity":"drug:interferon-beta-1b|betaseron"},{"fact_id":"f658b1c6606894b84d644a8b","field":"drug.partd_spending","entity":"drug:interferon-beta-1b|betaseron"},{"fact_id":"ed6eb411549ee00199da665b","field":"drug.biologic_status","entity":"application:BLA103471"},{"fact_id":"a4a842e809a83b3d77e0c522","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419052435:PA"}],"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:BLA103471","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":"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."}