{"answer":{"query":"Rebif","resolved_as":"applications","packages":6,"applications":["BLA103780"],"identity":{"application_numbers":["BLA103780"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2002-03-07","latest":"2012-12-21","packages_with_a_start_date":6}},"label_history":{"events_total":17,"non_cmc_events":16,"counts_by_class":{"LABELING":11,"EFFICACY":4,"S":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA103780","submission_no":5214,"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/2023/103780s5214lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-07-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103780Orig1s5214ltr.pdf","untrusted":true}}],"fact_id":"9d4de4c4f14f38b5febb4ed2"},{"application":"BLA103780","submission_no":5210,"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/2021/103780Orig1s5210ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-11-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103780s5210lbl.pdf","untrusted":true}}],"fact_id":"781d4850c729eb6b375fac92"},{"application":"BLA103780","submission_no":5207,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-05-26","documents":[{"type":"Label","date":"2020-05-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-05-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103780Orig1s5203s5207ltr.pdf","untrusted":true}}],"fact_id":"a871e89f64765b97436120be"},{"application":"BLA103780","submission_no":5203,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-05-26","documents":[{"type":"Label","date":"2020-05-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-05-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103780Orig1s5203s5207ltr.pdf","untrusted":true}}],"fact_id":"d452942e068bb87883de8afc"},{"application":"BLA103780","submission_no":5204,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-07-09","documents":[{"type":"Letter","date":"2019-07-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103780Orig1s5204ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-07-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103780s5204lbl.pdf","untrusted":true}}],"fact_id":"3576db22a016fc7bc65d6b2e"}],"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":"BLA103780","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"REBIF","untrusted":true},"form":{"text":"SYRINGE","untrusted":true},"strength":{"text":"22UG/0.5ML","untrusted":true}},{"application":"BLA103780","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"REBIF","untrusted":true},"form":{"text":"SYRINGE","untrusted":true},"strength":{"text":"44UG/0.5ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Interferon Beta-1a/Albumin","untrusted":true},"brand":{"text":"Rebif","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":232708460.75,"claims":25470,"beneficiaries":2795,"average_spending_per_claim_usd":9136.5708971,"fact_id":"ed611fb4259fbbccddfe7e23"},{"year":2021,"gross_spending_usd":198665887.89,"claims":20587,"beneficiaries":2311,"average_spending_per_claim_usd":9650.0649871,"fact_id":"7a3ec2e9f4577ba993f4a2bb"},{"year":2022,"gross_spending_usd":162331588.35,"claims":16085,"beneficiaries":1815,"average_spending_per_claim_usd":10092.109938,"fact_id":"6cb18220acd2190b25a4887b"},{"year":2023,"gross_spending_usd":131300521,"claims":11998,"beneficiaries":1364,"average_spending_per_claim_usd":10943.534006,"fact_id":"fddf6bb8c6d87e88706b3968"},{"year":2024,"gross_spending_usd":105377037.04,"claims":9289,"beneficiaries":1048,"average_spending_per_claim_usd":11344.282166,"fact_id":"f9e719f9be723b5c78b6ac67"}],"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":"BLA103780","status":"Reference","name":{"text":"Rebif","untrusted":true},"proper_name":{"text":"interferon beta-1a","untrusted":true},"license_status":"Licensed","approval_date":"2002-03-07","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":"2c188465d9c6653feb2843bc"}],"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":597263.08,"all_states_medicaid_paid_prescriptions":56,"top_states":[{"state":"OH","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":597263.08,"total_reimbursed_usd":597263.08,"packages":1,"covers":"fee_for_service_only","fact_id":"3d6cd83187fcd0205d9e4dcc"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":1,"older_year_facts_not_used":20,"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":"4a4bce04fac9298c3b8c4781","field":"ndc.listing","entity":"ndc:44087002203"},{"fact_id":"cdca0b80dae4cc2b140171e5","field":"ndc.listing","entity":"ndc:44087004403"},{"fact_id":"faf068c946a7831fc661f077","field":"ndc.listing","entity":"ndc:44087018801"},{"fact_id":"9d4de4c4f14f38b5febb4ed2","field":"drug.label_event","entity":"application:BLA103780"},{"fact_id":"781d4850c729eb6b375fac92","field":"drug.label_event","entity":"application:BLA103780"},{"fact_id":"a871e89f64765b97436120be","field":"drug.label_event","entity":"application:BLA103780"},{"fact_id":"d452942e068bb87883de8afc","field":"drug.label_event","entity":"application:BLA103780"},{"fact_id":"3576db22a016fc7bc65d6b2e","field":"drug.label_event","entity":"application:BLA103780"},{"fact_id":"e5339741ea001685ae43bb06","field":"drug.marketing_status","entity":"application:BLA103780"},{"fact_id":"3735fb496a3cf92d405e9df0","field":"drug.marketing_status","entity":"application:BLA103780"},{"fact_id":"ed611fb4259fbbccddfe7e23","field":"drug.partd_spending","entity":"drug:interferon-beta-1a-albumin|rebif"},{"fact_id":"7a3ec2e9f4577ba993f4a2bb","field":"drug.partd_spending","entity":"drug:interferon-beta-1a-albumin|rebif"},{"fact_id":"6cb18220acd2190b25a4887b","field":"drug.partd_spending","entity":"drug:interferon-beta-1a-albumin|rebif"},{"fact_id":"fddf6bb8c6d87e88706b3968","field":"drug.partd_spending","entity":"drug:interferon-beta-1a-albumin|rebif"},{"fact_id":"f9e719f9be723b5c78b6ac67","field":"drug.partd_spending","entity":"drug:interferon-beta-1a-albumin|rebif"},{"fact_id":"2c188465d9c6653feb2843bc","field":"drug.biologic_status","entity":"application:BLA103780"},{"fact_id":"3d6cd83187fcd0205d9e4dcc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:44087334401:OH"}],"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:BLA103780","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."}