{"answer":{"query":"Kesimpta","resolved_as":"applications","packages":2,"applications":["BLA125326"],"identity":{"application_numbers":["BLA125326"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2020-08-20","latest":"2020-08-20","packages_with_a_start_date":2}},"label_history":{"events_total":12,"non_cmc_events":12,"counts_by_class":{"LABELING":8,"EFFICACY":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA125326","submission_no":84,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-04-01","documents":[{"type":"Label","date":"2026-04-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125326s084lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-04-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125326Orig1s084ltr.pdf","untrusted":true}}],"fact_id":"768073fb1ba8edaf97a4b9aa"},{"application":"BLA125326","submission_no":83,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-18","documents":[{"type":"Letter","date":"2025-08-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125326Orig1s083ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125326s083lbl.pdf","untrusted":true}}],"fact_id":"72505ac2cf8a4e105f9405f0"},{"application":"BLA125326","submission_no":79,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-12","documents":[{"type":"Label","date":"2024-04-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-04-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125326Orig1s079ltr.pdf","untrusted":true}}],"fact_id":"439a1f33507cf9de1ea5b376"},{"application":"BLA125326","submission_no":80,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-19","documents":[{"type":"Label","date":"2024-01-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s080lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-01-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125326Orig1s080ltr.pdf","untrusted":true}}],"fact_id":"2232df95daa8bd16f26c71fb"},{"application":"BLA125326","submission_no":75,"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/2022/125326Orig1s075ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-09-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125326s075lbl.pdf","untrusted":true}}],"fact_id":"6b8acd478cd86d2c7ebf29ba"}],"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":"BLA125326","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KESIMPTA","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"20MG/0.4ML","untrusted":true}},{"application":"BLA125326","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARZERRA","untrusted":true},"form":{"text":"INJECTABLE; INJECTION","untrusted":true},"strength":{"text":"100MG/5ML","untrusted":true}}]},"biologic_status":{"products":[{"application":"BLA125326","status":"Reference","name":{"text":"Arzerra; Kesimpta","untrusted":true},"proper_name":{"text":"ofatumumab","untrusted":true},"license_status":"Licensed","approval_date":"2009-10-26","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":"a0ada37d84391c21b398df78"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"ofatumumab","untrusted":true},"designation_count":4,"approved_count":4,"recent":[{"designated":"2009-03-10","use":{"text":"Treatment of chronic lymphocytic leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true},{"designated":"2009-03-10","use":{"text":"Treatment of chronic lymphocytic leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true},{"designated":"2009-03-10","use":{"text":"Treatment of chronic lymphocytic leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true},{"designated":"2009-03-10","use":{"text":"Treatment of chronic lymphocytic leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"f60c62fee8b58b65f6fb4c39"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2024,"states_with_data":48,"all_states_medicaid_reimbursed_usd":320355599.38,"all_states_medicaid_paid_prescriptions":34133,"top_states":[{"state":"CA","medicaid_paid_prescriptions":3203,"medicaid_reimbursed_usd":33950941.82,"total_reimbursed_usd":34244017.87,"packages":1,"covers":"all_record_types","fact_id":"deea0d0b9a5890080508181a"},{"state":"NY","medicaid_paid_prescriptions":2417,"medicaid_reimbursed_usd":24515076.94,"total_reimbursed_usd":24593134.25,"packages":1,"covers":"all_record_types","fact_id":"7b8d37dd03c53a6ee801206b"},{"state":"OH","medicaid_paid_prescriptions":1992,"medicaid_reimbursed_usd":19179830.02,"total_reimbursed_usd":19347492.59,"packages":1,"covers":"all_record_types","fact_id":"8954deec287c981356ad2600"},{"state":"NC","medicaid_paid_prescriptions":1697,"medicaid_reimbursed_usd":17843525.27,"total_reimbursed_usd":18617932.22,"packages":1,"covers":"all_record_types","fact_id":"07904e942a7899cd90bd7161"},{"state":"LA","medicaid_paid_prescriptions":1698,"medicaid_reimbursed_usd":15313584.36,"total_reimbursed_usd":15944232.33,"packages":1,"covers":"fee_for_service_only","fact_id":"0130306b86ab7c6a6edaa638"},{"state":"MI","medicaid_paid_prescriptions":1629,"medicaid_reimbursed_usd":14595357.89,"total_reimbursed_usd":14628779.68,"packages":1,"covers":"all_record_types","fact_id":"549e6d543c15e796796eea87"},{"state":"PA","medicaid_paid_prescriptions":1513,"medicaid_reimbursed_usd":13927567.43,"total_reimbursed_usd":14546976.58,"packages":1,"covers":"fee_for_service_only","fact_id":"6038371405cee58fb79bec4d"},{"state":"FL","medicaid_paid_prescriptions":1342,"medicaid_reimbursed_usd":12331090.78,"total_reimbursed_usd":12427599.16,"packages":1,"covers":"fee_for_service_only","fact_id":"42c96a75c7c9eba5d81a316c"},{"state":"TX","medicaid_paid_prescriptions":1417,"medicaid_reimbursed_usd":12303705.95,"total_reimbursed_usd":12720866.51,"packages":1,"covers":"fee_for_service_only","fact_id":"dab7d0de7ae5873cd953328d"},{"state":"WA","medicaid_paid_prescriptions":1291,"medicaid_reimbursed_usd":11845616.12,"total_reimbursed_usd":12099408.97,"packages":1,"covers":"fee_for_service_only","fact_id":"59e78eec67827b7c02afc4fb"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":34999,"medicaid_reimbursed_usd":327869412.79,"note":"the source uses the code XX without defining it; 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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. 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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:BLA125326","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":"spending","reason":"no CMS Part D spending series for this brand name is in the edition"},{"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":"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."}