{"answer":{"query":"Soliris","resolved_as":"applications","packages":1,"applications":["BLA125166"],"identity":{"application_numbers":["BLA125166"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION, CONCENTRATE","untrusted":true}],"marketing_start":{"earliest":"2007-04-02","latest":"2007-04-02","packages_with_a_start_date":1}},"label_history":{"events_total":27,"non_cmc_events":27,"counts_by_class":{"REMS":9,"LABELING":13,"EFFICACY":5},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA125166","submission_no":455,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-10-21","documents":[{"type":"Letter","date":"2026-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125166Orig1s455, 761108Orig1s046ltr.pdf","untrusted":true}}],"fact_id":"e0f381bd5d44fbeadf9cd7d8"},{"application":"BLA125166","submission_no":454,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-30","documents":[{"type":"Letter","date":"2026-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125166Orig1s454ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125166s454lbl.pdf","untrusted":true}}],"fact_id":"5676e7925c88aff2bb0ee87d"},{"application":"BLA125166","submission_no":453,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-06-01","documents":[{"type":"Letter","date":"2026-06-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125166Orig1s453; 761108Orig1s045ltr.pdf","untrusted":true}}],"fact_id":"bc90bcb45928ecf41f9964ee"},{"application":"BLA125166","submission_no":450,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2025-06-27","documents":[{"type":"Letter","date":"2025-06-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761108Orig1s040;125166Orig1s450ltr.pdf","untrusted":true}}],"fact_id":"7030f4fbe6dce1a0190024f7"},{"application":"BLA125166","submission_no":448,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-02-28","documents":[{"type":"Label","date":"2025-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125166s448,761108s038lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125166Orig1s448, 761108Orig1s038ltr.pdf","untrusted":true}}],"fact_id":"782f7bdf132f84e7385e0354"}],"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":"BLA125166","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SOLIRIS","untrusted":true},"form":{"text":"INJECTABLE; IV (INFUSION)","untrusted":true},"strength":{"text":"300MG","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class I":2},"packages_of_these_applications":1,"most_recent":[{"recall_number":"D-1512-2014","classification":"Class I","status":"Terminated","report_date":"2014-08-13","recall_initiated":"2014-06-02","recalling_firm":{"text":"Alexion Pharmaceuticals, Inc.","untrusted":true},"reason":{"text":"Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.","untrusted":true},"packages_named":1,"fact_id":"c2839dc917e25df1543b55da"},{"recall_number":"D-1049-2014","classification":"Class I","status":"Terminated","report_date":"2014-02-05","recall_initiated":"2013-11-04","recalling_firm":{"text":"Alexion Pharmaceuticals, Inc.","untrusted":true},"reason":{"text":"Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.","untrusted":true},"packages_named":1,"fact_id":"7c71d1b894bd1d693b26f332"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Eculizumab","untrusted":true},"brand":{"text":"Soliris","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":210563941.8,"claims":5013,"beneficiaries":462,"average_spending_per_claim_usd":42003.579054,"fact_id":"e242901e8ee37ac115f75b2d"},{"year":2021,"gross_spending_usd":245754920.21,"claims":5746,"beneficiaries":521,"average_spending_per_claim_usd":42769.738985,"fact_id":"59baa14c9a031957582f800c"},{"year":2022,"gross_spending_usd":266299810.72,"claims":6175,"beneficiaries":566,"average_spending_per_claim_usd":43125.47542,"fact_id":"a987a612a69798cd75ce95e9"},{"year":2023,"gross_spending_usd":223473529.4,"claims":5063,"beneficiaries":462,"average_spending_per_claim_usd":44138.560024,"fact_id":"f52ba1bc74ed786c735649fd"},{"year":2024,"gross_spending_usd":196193578.99,"claims":4569,"beneficiaries":419,"average_spending_per_claim_usd":42940.157363,"fact_id":"66ad3f7a1e04f4ad742c9323"}],"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":"BLA125166","status":"Reference","name":{"text":"Soliris","untrusted":true},"proper_name":{"text":"eculizumab","untrusted":true},"license_status":"Licensed","approval_date":"2007-03-16","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":2,"biosimilars":[],"interchangeables":[{"name":{"text":"Bkemv","untrusted":true},"proper_name":{"text":"eculizumab-aeeb","untrusted":true},"bla_number":"761333","approval_date":"2024-05-28","interchangeable_date":"2024-05-28"},{"name":{"text":"Epysqli","untrusted":true},"proper_name":{"text":"eculizumab-aagh","untrusted":true},"bla_number":"761340","approval_date":"2024-07-19","interchangeable_date":"2025-11-28"}],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"b0e71c20c8b8c7b47ee4bca2"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J1299","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":43.763,"dosage_descriptor":{"text":"2 MG","untrusted":true},"packages_matched":1,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"b50e39b540e92c377eb45fa1"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; 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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:BLA125166","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":"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":"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."}