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
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
encelto	125798	001	351(a)	revakinagene taroretcel-lwey	Implant	Implantation	200,000-440,000CELLS/IMPLANT	Capsule	2025/03/05	Neurotech Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
TNKase	103909	002	351(a)	tenecteplase	For Injection	Intravenous	25MG	Single-Dose Vial	2025/02/28	Genentech, Inc.	Rx	Licensed	N/A	N/A
Stoboclo	761404	001	351(k) Interchangeable	denosumab-bmwo	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/02/28	CELLTRION, Inc.	Rx	Licensed	denosumab	Prolia
Osenvelt	761404	002	351(k) Interchangeable	denosumab-bmwo	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/02/28	CELLTRION, Inc.	Rx	Licensed	denosumab	Xgeva
Glassia	125325	002	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	4G	Single-Dose Vial	2025/02/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Glassia	125325	003	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	5G	Single-Dose Vial	2025/02/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
PENMENVY	125819	001	351(a)	Meningococcal Groups A, B, C, W and Y Vaccine	Injection	Intramuscular	25UG/0.5ML	Single-Dose Vial	2025/02/14	GlaxoSmithKline Biologicals	Rx	Licensed	N/A	N/A
VIMKUNYA	125820	001	351(a)	Chikungunya Vaccine, Recombinant	Injection	Intramuscular	40UG/0.8ML	Pre-Filled Syringe	2025/02/14	Bavarian Nordic A/S	Rx	Licensed	N/A	N/A
Simlandi	761299	005	351(k) Interchangeable	adalimumab-ryvk	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2025/02/14	Alvotech USA Inc.	Rx	Licensed	adalimumab	Humira
Merilog	761325	001	351(k) Biosimilar	insulin aspart-szjj	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2025/02/14	Sanofi-Aventis U.S. LLC	Rx	Licensed	insulin aspart	Novolog
Merilog	761325	002	351(k) Biosimilar	insulin aspart-szjj	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2025/02/14	Sanofi-Aventis U.S. LLC	Rx	Licensed	insulin aspart	Novolog
Ospomyv	761392	001	351(k) Interchangeable	denosumab-dssb	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/02/13	Samsung Bioepis Co., Ltd.	Rx	Licensed	denosumab	Prolia
Xbryk	761392	002	351(k) Interchangeable	denosumab-dssb	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/02/13	Samsung Bioepis Co., Ltd.	Rx	Licensed	denosumab	Xgeva
Selarsdi	761343	004	351(k) Interchangeable	ustekinumab-aekn	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2025/02/12	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara

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	-