{"answer":{"query":"Tremfya","resolved_as":"applications","packages":10,"applications":["BLA761061"],"identity":{"application_numbers":["BLA761061"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2017-07-13","latest":"2025-03-25","packages_with_a_start_date":10}},"label_history":{"events_total":14,"non_cmc_events":13,"counts_by_class":{"EFFICACY":9,"LABELING":4},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA761061","submission_no":34,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-05-28","documents":[{"type":"Letter","date":"2026-05-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761061Orig1s034ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761061s034lbl.pdf","untrusted":true}}],"fact_id":"f0633b592019498115fa1fad"},{"application":"BLA761061","submission_no":29,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-09-26","documents":[{"type":"Label","date":"2025-09-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761061s028s029lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-09-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761061Orig1s028s029ltr.pdf","untrusted":true}}],"fact_id":"07f1e58d534816f3e966bf51"},{"application":"BLA761061","submission_no":28,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-09-26","documents":[{"type":"Label","date":"2025-09-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761061s028s029lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-09-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761061Orig1s028s029ltr.pdf","untrusted":true}}],"fact_id":"c2293987b74b150d9ac95b98"},{"application":"BLA761061","submission_no":26,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-09-19","documents":[{"type":"Label","date":"2025-09-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761061s026lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761061Orig1s026ltr.pdf","untrusted":true}}],"fact_id":"7ddd5a8dc4dc4f67f7219b02"},{"application":"BLA761061","submission_no":30,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-17","documents":[{"type":"Letter","date":"2025-06-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761061Orig1s030ltr.pdf","untrusted":true}}],"fact_id":"dbe7f7912189eaa0d3755de5"}],"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":"BLA761061","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TREMFYA","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"100MG/ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class III":1},"packages_of_these_applications":10,"most_recent":[{"recall_number":"D-0314-2021","classification":"Class III","status":"Terminated","report_date":"2021-04-07","recall_initiated":"2021-03-09","recalling_firm":{"text":"Cardinal Health Inc.","untrusted":true},"reason":{"text":"Temperature Abuse","untrusted":true},"packages_named":1,"fact_id":"4a34e0435a4aac03fe2a5bce"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Guselkumab","untrusted":true},"brand":{"text":"Tremfya*","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":167392577.77,"claims":14355,"beneficiaries":3469,"average_spending_per_claim_usd":11660.924958,"fact_id":"691b1c297452854596194a20"},{"year":2021,"gross_spending_usd":285251576.87,"claims":23040,"beneficiaries":5687,"average_spending_per_claim_usd":12380.710802,"fact_id":"39bf58d14ee1aba788bbded2"},{"year":2022,"gross_spending_usd":439124671.06,"claims":33444,"beneficiaries":7918,"average_spending_per_claim_usd":13130.14804,"fact_id":"c69f1d70865783ad3d04a4eb"},{"year":2023,"gross_spending_usd":531497097.62,"claims":38622,"beneficiaries":8945,"average_spending_per_claim_usd":13761.511512,"fact_id":"d3044b32b06ccef76ce07ef3"},{"year":2024,"gross_spending_usd":618784543.17,"claims":46079,"beneficiaries":10848,"average_spending_per_claim_usd":13428.775433,"fact_id":"0fffaa560573758c8502ad68"}],"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":"BLA761061","status":"Reference","name":{"text":"Tremfya","untrusted":true},"proper_name":{"text":"guselkumab","untrusted":true},"license_status":"Licensed","approval_date":"2017-07-13","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":"08a023c4dae04dde61d8388a"}],"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":"J1628","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":66.998,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":7,"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":"9e010efa75f8381cf7534083"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"medicaid_state_utilization":{"year":2025,"states_with_data":2,"all_states_medicaid_reimbursed_usd":5929772.9,"all_states_medicaid_paid_prescriptions":422,"top_states":[{"state":"CA","medicaid_paid_prescriptions":229,"medicaid_reimbursed_usd":3276279.08,"total_reimbursed_usd":3317245.02,"packages":1,"covers":"fee_for_service_only","fact_id":"7d5f88a6936c79a64be38aaf"},{"state":"NV","medicaid_paid_prescriptions":193,"medicaid_reimbursed_usd":2653493.82,"total_reimbursed_usd":2688003.47,"packages":1,"covers":"all_record_types","fact_id":"324aa8ccfb9a77b0487ea395"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":3136,"medicaid_reimbursed_usd":48524333.6,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":5,"facts_fee_for_service_only":3,"older_year_facts_not_used":62,"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). 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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:BLA761061","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":"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."}