| 商品名 | 申请号 | 产品号 | BLA类型 | 非专利名称 | 剂型 | 给药途径 | 规格/剂量 | 产品形式 | 批准日期 | 申请人 | 市场状态 | 许可证状态 | 参考产品非专利名称 | 参考产品专利名称 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ziihera | 761416 | 001 | 351(a) | zanidatamab-hrii | For Injection | Intravenous | 300MG | Single-Dose Vial | 2024/11/20 | Jazz Pharmaceuticals Ireland Limited | Rx | Licensed | ||
| KEBILIDI | 125722 | 001 | 351(a) | eladocagene exuparvovec-tneq | Suspension | Intraputaminal | 5.6x10^11VG/ML | Single-Dose Vial | 2024/11/13 | PTC Therapeutics | Rx | Licensed | ||
| Aucatzyl | 125813 | 001 | 351(a) | Obecabtagene autoleucel | Suspension | Intravenous | 10 × 10^6CELL/ML | Bag | 2024/11/08 | Autolus, Inc. | Rx | Licensed | ||
| Aucatzyl | 125813 | 002 | 351(a) | Obecabtagene autoleucel | Suspension | Intravenous | 100 × 10^6CELL/ML | Bag | 2024/11/08 | Autolus, Inc. | Rx | Licensed | ||
| Aucatzyl | 125813 | 003 | 351(a) | Obecabtagene autoleucel | Suspension | Intravenous | 300 × 10^6CELL/ML | Bag | 2024/11/08 | Autolus, Inc. | Rx | Licensed | ||
| Selarsdi | 761343 | 003 | 351(k) Biosimilar | ustekinumab-aekn | Injection | Intravenous | 130MG/26ML (5MG/ML) | Single-Dose Vial | 2024/10/18 | Alvotech USA Inc. | Rx | Licensed | ustekinumab | Stelara |
| Vyloy | 761365 | 001 | 351(a) | zolbetuximab-clzb | Injection | Intravenous | 100MG | Single-Dose Vial | 2024/10/18 | Astellas Pharma US, Inc. | Rx | Licensed | ||
| Bimzelx | 761151 | 003 | 351(a) | bimekizumab-bkzx | Injection | Subcutaneous | 320MG/2ML (160MG/2ML) | Pre-Filled Syringe | 2024/10/11 | UCB, Inc. | Rx | Licensed | ||
| Bimzelx | 761151 | 004 | 351(a) | bimekizumab-bkzx | Injection | Subcutaneous | 320MG/2ML (160MG/2ML) | Autoinjector | 2024/10/11 | UCB, Inc. | Rx | Licensed | ||
| Hympavzi | 761369 | 001 | 351(a) | marstacimab-hncq | Injection | Subcutaneous | 150MG/ML | Pre-Filled Syringe | 2024/10/11 | Pfizer Inc. | Rx | Licensed | ||
| Hympavzi | 761369 | 002 | 351(a) | marstacimab-hncq | Injection | Subcutaneous | 150MG/ML | Autoinjector | 2024/10/11 | Pfizer Inc. | Rx | Licensed | ||
| Imuldosa | 761364 | 001 | 351(k) Biosimilar | ustekinumab-srlf | Injection | Subcutaneous | 45MG/0.5ML | Pre-Filled Syringe | 2024/10/10 | Accord BioPharma Inc. | Rx | Licensed | ustekinumab | Stelara |
| Imuldosa | 761364 | 002 | 351(k) Biosimilar | ustekinumab-srlf | Injection | Subcutaneous | 90MG/ML | Pre-Filled Syringe | 2024/10/10 | Accord BioPharma Inc. | Rx | Licensed | ustekinumab | Stelara |
| Imuldosa | 761364 | 003 | 351(k) Biosimilar | ustekinumab-srlf | Injection | Intravenous | 130MG/26ML (5MG/ML) | Single-Dose Vial | 2024/10/10 | Accord BioPharma Inc. | Rx | Licensed | ustekinumab | Stelara |
| Otulfi | 761379 | 001 | 351(k) Biosimilar | ustekinumab-aauz | Injection | Subcutaneous | 45MG/0.5ML | Pre-Filled Syringe | 2024/09/27 | Fresenius Kabi USA, LLC | Rx | Licensed | ustekinumab | Stelara |
| Otulfi | 761379 | 002 | 351(k) Biosimilar | ustekinumab-aauz | Injection | Subcutaneous | 90MG/ML | Pre-Filled Syringe | 2024/09/27 | Fresenius Kabi USA, LLC | Rx | Licensed | ustekinumab | Stelara |
| Otulfi | 761379 | 003 | 351(k) Biosimilar | ustekinumab-aauz | Injection | Intravenous | 130MG/26ML (5MG/ML) | Single-Dose Vial | 2024/09/27 | Fresenius Kabi USA, LLC | Rx | Licensed | ustekinumab | Stelara |
| Ocrevus Zunovo | 761371 | 001 | 351(a) | ocrelizumab and hyaluronidase-ocsq | Injection | Subcutaneous | 920MG/23ML; 23,000UNITS/23ML (40MG/1,000UNITS/ML) | Single-Dose Vial | 2024/09/13 | Genentech, Inc. | Rx | Licensed | ||
| Ebglyss | 761306 | 001 | 351(a) | lebrikizumab-lbkz | Injection | Subcutaneous | 250MG/2ML | Autoinjector | 2024/09/13 | Eli Lilly and Company | Rx | Licensed | ||
| Ebglyss | 761306 | 002 | 351(a) | lebrikizumab-lbkz | Injection | Subcutaneous | 250MG/2ML | Pre-Filled Syringe | 2024/09/13 | Eli Lilly and Company | Rx | Licensed |
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