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
Tyenne	761275	002	351(k) Biosimilar	tocilizumab-aazg	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2024/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Tyenne	761275	003	351(k) Biosimilar	tocilizumab-aazg	Injection	Intravenous	400MG/20ML (20MG/ML)	Single-Dose Vial	2024/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Jubbonti	761362	001	351(k) Interchangeable	denosumab-bbdz	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2024/03/05	Sandoz Inc.	Disc	Licensed	denosumab	Prolia
Wyost	761362	002	351(k) Interchangeable	denosumab-bbdz	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2024/03/05	Sandoz Inc.	Disc	Licensed	denosumab	Xgeva
Flublok	125285	003	351(a)	Influenza Vaccine	Injection	Intramuscular	135UG/.5ML	Pre-Filled Syringe	2024/03/04	Protein Sciences Corporation	Rx	Licensed		N/A
Flucelvax, Flucelvax Quadrivalent	125408	004	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Multi-Dose Vial	2024/03/04	Seqirus Inc.	Rx	Licensed	N/A	N/A
Flucelvax, Flucelvax Quadrivalent	125408	005	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	2024/03/04	Seqirus Inc.	Rx	Licensed	N/A	N/A
Letybo	761225	001	351(a)	letibotulinumtoxinA-wlbg	For Injection	Intramuscular	50UNITS	Single-Dose Vial	2024/02/29	Hugel, Inc.	Rx	Licensed	N/A	N/A
Letybo	761225	002	351(a)	letibotulinumtoxinA-wlbg	For Injection	Intramuscular	100UNITS	Single-Dose Vial	2024/02/29	Hugel, Inc.	Rx	Licensed	N/A	N/A
Simlandi	761299	001	351(k) Interchangeable	adalimumab-ryvk	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2024/02/23	Alvotech USA Inc.	Rx	Licensed	adalimumab	Humira
AMTAGVI	125773	001	351(a)	Lifileucel	Suspension	Intravenous	7.5x10^9 to 72x10^9Cells	Bag	2024/02/16	Iovance Biotherapeutics, Inc.	Rx	Licensed	N/A	N/A
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

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	-