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
Hemlibra	761083	006	351(a)	emicizumab-kxwh	Injection	Subcutaneous	12MG/0.4ML	Single-Dose Vial	2024/01/31	Genentech, Inc.	Rx	Licensed	N/A	N/A
Idacio	761255	003	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Single-Dose Vial	2024/01/05	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira
Udenyca Onbody	761039	003	351(k) Biosimilar	pegfilgrastim-cbqv	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2023/12/22	Accord BioPharma Inc.	Rx	Licensed	pegfilgrastim	Neulasta
Alyglo	125743	001	351(a)	immune globulin intravenous, human-stwk	Injection	Intravenous	10% 100MG/ML	Single-Dose Vial	2023/12/15	GC Biopharma Corp.	Rx	Licensed	N/A	N/A
Casgevy	125787	001	351(a)	Exagamglogene autotemcel	Suspension	Intravenous	4-13 × 10^6 CELL/ML	Single-Dose Vial	2023/12/08	Vertex Pharmaceuticals Inc	Rx	Licensed	N/A	N/A
LYFGENIA	125788	001	351(a)	lovotibeglogene autotemcel	Suspension	Intravenous	1.7-20x10^6CELL/ML	Bag	2023/12/08	bluebird bio Inc.	Rx	Licensed	N/A	N/A
Avzivi	761198	001	351(k) Biosimilar	bevacizumab-tnjn	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2023/12/06	Bio-Thera Solutions, Ltd.	Rx	Licensed	bevacizumab	Avastin
Avzivi	761198	002	351(k) Biosimilar	bevacizumab-tnjn	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2023/12/06	Bio-Thera Solutions, Ltd.	Rx	Licensed	bevacizumab	Avastin
Ryzneuta	761134	001	351(a)	efbemalenograstim alfa-vuxw	Injection	Subcutaneous	20MG/ML	Pre-Filled Syringe	2023/11/16	Evive Biotechnology Singapore PTE. LTD.	Rx	Licensed	N/A	N/A
IXCHIQ	125777	001	351(a)	Chikungunya Vaccine, Live	For Injection	Intramuscular	3.0 log10 TCID	Single-Dose Vial	2023/11/09	Valneva Austria GmbH	Rx	Licensed	N/A	N/A
ADZYNMA	125795	001	351(a)	ADAMTS13, recombinant-krhn	For Injection	Intravenous	500IU	Single-Dose Vial	2023/11/09	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
ADZYNMA	125795	002	351(a)	ADAMTS13, recombinant-krhn	For Injection	Intravenous	1500IU	Single-Dose Vial	2023/11/09	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Wezlana	761285	001	351(k) Interchangeable	ustekinumab-auub	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Wezlana	761285	002	351(k) Interchangeable	ustekinumab-auub	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Wezlana	761285	003	351(k) Interchangeable	ustekinumab-auub	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Wezlana	761331	001	351(k) Interchangeable	ustekinumab-auub	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Zenpep	022210	008	351(a)	pancrelipase	Capsule, Delayed Release	Oral	60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS		2023/10/27	Zenpep, LLC	Rx	Licensed	N/A	N/A
Loqtorzi	761240	001	351(a)	toripalimab-tpzi	Injection	Intravenous	240MG/6ML (40MG/ML)	Single-Dose Vial	2023/10/27	Coherus BioSciences, Inc.	Rx	Licensed	N/A	N/A
Omvoh	761279	001	351(a)	mirikizumab-mrkz	Injection	Intravenous	300MG/15ML (20MG/ML)	Single-Dose Vial	2023/10/26	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Omvoh	761279	002	351(a)	mirikizumab-mrkz	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2023/10/26	Eli Lilly and Company	Rx	Licensed	N/A	N/A

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	-