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
Emrelis	761384	001	351(a)	telisotuzumab vedotin-tllv	Injection	Intravenous	20MG	Single-Dose Vial	2025/05/14	AbbVie Inc.	Rx	Licensed	N/A	N/A
Emrelis	761384	002	351(a)	telisotuzumab vedotin-tllv	Injection	Intravenous	100MG	Single-Dose Vial	2025/05/14	AbbVie Inc.	Rx	Licensed	N/A	N/A
Humalog	205747	002	351(a)	insulin lispro	Injection	Subcutaneous	600UNITS/3ML (200UNITS/ML)	Autoinjector	2025/05/07	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Imaavy	761430	001	351(a)	nipocalimab-aahu	Injection	Intravenous	300MG/1.62ML (185MG/ML)	Single-Dose Vial	2025/04/29	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Imaavy	761430	002	351(a)	nipocalimab-aahu	Injection	Intravenous	1,200MG/6.5ML (185MG/ML)	Single-Dose Vial	2025/04/29	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
zevaskyn	125807	001	351(a)	Prademagene zamikeracel	Cellular Sheet	Topical	41.25CM^2	Tray & Lid	2025/04/28	Abeona Therapeutics Inc.	Rx	Licensed	N/A	N/A
	761258	001	351(a)	penpulimab-kcqx	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2025/04/23	Akeso Biopharma Co., Ltd.	Rx	Licensed	N/A	N/A
Vyvgart Hytrulo	761304	002	351(a)	efgartigimod alfa and hyaluronidase-qvfc	Injection	Subcutaneous	1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML)	Pre-Filled Syringe	2025/04/10	Argenx BV	Rx	Licensed	N/A	N/A
Jobevne	761175	001	351(k) Biosimilar	bevacizumab-nwgd	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2025/04/09	Biocon Biologics Inc.	Rx	Licensed	bevacizumab	Avastin
Jobevne	761175	002	351(k) Biosimilar	bevacizumab-nwgd	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2025/04/09	Biocon Biologics Inc.	Rx	Licensed	bevacizumab	Avastin
Conexxence	761398	001	351(k) Biosimilar	denosumab-bnht	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/03/25	Fresenius Kabi USA, LLC	Rx	Licensed	denosumab	Prolia
Bomyntra	761398	002	351(k) Biosimilar	denosumab-bnht	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/03/25	Fresenius Kabi USA, LLC	Rx	Licensed	denosumab	Xgeva
Bomyntra	761398	003	351(k) Biosimilar	denosumab-bnht	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Pre-Filled Syringe	2025/03/25	Fresenius Kabi USA, LLC	Rx	Licensed	denosumab	Xgeva
Vyloy	761365	002	351(a)	zolbetuximab-clzb	Injection	Intravenous	300MG	Single-Dose Vial	2025/03/24	Astellas Pharma US, Inc.	Rx	Licensed	N/A	N/A
Jynneos	125678	002	351(a)	Smallpox and Mpox Vaccine, Live, Non-replicating	For Injection	Subcutaneous	0.5-3.95 X 10E8 INF. U/.5ML	Single-Dose Vial	2025/03/21	Bavarian Nordic A/S	Rx	Licensed	N/A	N/A
Otulfi	761379	004	351(k) Interchangeable	ustekinumab-aauz	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2025/03/21	Fresenius Kabi USA, LLC	Rx	Licensed	ustekinumab	Stelara
Tyenne	761449	001	351(k) Biosimilar	tocilizumab-aazg	Injection	Subcutaneous	162MG/0.9ML	Pre-Filled Syringe	2025/03/14	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Tyenne	761449	002	351(k) Biosimilar	tocilizumab-aazg	Injection	Subcutaneous	162MG/0.9ML	Autoinjector	2025/03/14	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Omlyclo	761399	001	351(k) Interchangeable	omalizumab-igec	Injection	Subcutaneous	75MG/0.5ML	Pre-Filled Syringe	2025/03/07	CELLTRION, Inc.	Rx	Licensed	omalizumab	Xolair
Omlyclo	761399	002	351(k) Interchangeable	omalizumab-igec	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2025/03/07	CELLTRION, Inc.	Rx	Licensed	omalizumab	Xolair

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	-