美国FDA生物制品紫皮书数据库（U.S. FDA Purple Book: Database of Licensed Biological Products）- 药物在线

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
Selarsdi	761343	003	351(k) Interchangeable	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	N/A	N/A
Bimzelx	761151	003	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	320MG/2ML (160MG/2ML)	Pre-Filled Syringe	2024/10/11	UCB, Inc.	Rx	Licensed	N/A	N/A
Bimzelx	761151	004	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	320MG/2ML (160MG/2ML)	Autoinjector	2024/10/11	UCB, Inc.	Rx	Licensed	N/A	N/A
Hympavzi	761369	001	351(a)	marstacimab-hncq	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2024/10/11	Pfizer Inc.	Rx	Licensed	N/A	N/A
Hympavzi	761369	002	351(a)	marstacimab-hncq	Injection	Subcutaneous	150MG/ML	Autoinjector	2024/10/11	Pfizer Inc.	Rx	Licensed	N/A	N/A
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) Interchangeable	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) Interchangeable	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) Interchangeable	ustekinumab-aauz	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/09/27	Fresenius Kabi USA, LLC	Rx	Licensed	ustekinumab	Stelara
Ebglyss	761306	001	351(a)	lebrikizumab-lbkz	Injection	Subcutaneous	250MG/2ML	Autoinjector	2024/09/13	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Ebglyss	761306	002	351(a)	lebrikizumab-lbkz	Injection	Subcutaneous	250MG/2ML	Pre-Filled Syringe	2024/09/13	Eli Lilly and Company	Rx	Licensed	N/A	N/A
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	N/A	N/A
Tecentriq Hybreza	761347	001	351(a)	atezolizumab and hyaluronidase-tqjs	Injection	Subcutaneous	1,875MG/15ML; 30,000UNITS/15ML (125MG/2,000UNITS/ML)	Single-Dose Vial	2024/09/12	Genentech, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	003	351(a)	guselkumab	Injection	Subcutaneous	200MG/2ML (100MG/ML)	Autoinjector	2024/09/11	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	004	351(a)	guselkumab	Injection	Subcutaneous	200MG/2ML (100MG/ML)	Pre-Filled Syringe	2024/09/11	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	005	351(a)	guselkumab	Injection	Intravenous	200MG/20ML (10MG/ML)	Single-Dose Vial	2024/09/11	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Hercessi	761346	002	351(k) Biosimilar	trastuzumab-strf	For Injection	Intravenous	420MG	Multi-Dose Vial	2024/09/06	Accord BioPharma Inc.	Rx	Licensed	trastuzumab	Herceptin

药品商品名或专利药名Proprietary (Brand) Name
药品通用名或非专利名称Nonproprietary (Proper) Name
药品申请号BLA Number
产品号Product Number
剂型Dosage Form
给药途径Route of Administration
产品形式Product Presentation
药品规格或剂量Strength
药品注册申请人Applicant
参考产品非专利名称Reference Product Proper Name
参考产品专利名称Reference Product Proprietary Name
BLA类型BLA Type
药品的市场状态Marketing Status
许可证号License Number
许可证状态Licensure
产品批准日期Approval Date	-