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
Zynteglo	125717	001	351(a)	betibeglogene autotemcel	For Injection	Intravenous	1.7-20 X 10^6CELL/ML	Bag	2022/08/17	Bluebird Bio Inc.	Rx	Licensed	N/A	N/A
Hadlima	761059	004	351(k) Interchangeable	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2022/08/15	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Hadlima	761059	005	351(k) Interchangeable	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2022/08/15	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Rebinyn	125611	004	351(a)	Coagulation Factor IX (Recombinant), GlycoPEGylated	For Injection	Intravenous	3000IU	Single-Dose Vial	2022/08/11	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Cimerli	761165	001	351(k) Interchangeable	ranibizumab-eqrn	Injection	Intravitreal	10MG/ML (0.5MG/0.05ML)	Single-Dose Vial	2022/08/02	Sandoz Inc.	Rx	Licensed	ranibizumab	Lucentis
Cimerli	761165	002	351(k) Interchangeable	ranibizumab-eqrn	Injection	Intravitreal	6MG/ML (0.3MG/0.05ML)	Single-Dose Vial	2022/08/02	Sandoz Inc.	Rx	Licensed	ranibizumab	Lucentis
Ultomiris	761108	004	351(a)	ravulizumab-cwvz	Injection	Subcutaneous	245MG/3.5ML (70MG/ML)	Single-Dose Cartridge	2022/06/22	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Hadlima	761059	003	351(k) Interchangeable	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.8ML	Single-Dose Vial	2022/06/17	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Skyrizi	761105	005	351(a)	risankizumab-rzaa	Injection	Subcutaneous	360MG/2.4ML (150MG/ML)	Single-Dose Cartridge	2022/06/16	AbbVie Inc.	Rx	Licensed	N/A	N/A
Skyrizi	761262	001	351(a)	risankizumab-rzaa	Injection	Intravenous	600MG/10ML (60MG/ML)	Single-Dose Vial	2022/06/16	AbbVie Inc.	Rx	Licensed	N/A	N/A
PRIORIX	125748	001	351(a)	Measles, Mumps and Rubella Vaccine Live	For Injection	Subcutaneous	3.4, 4.2 and 3.3LOG10	Single-Dose Vial	2022/06/03	GlaxoSmithKline Biologicals	Rx	Licensed	N/A	N/A
Beovu	761125	002	351(a)	brolucizumab-dbll	Injection	Intravitreal	6MG/0.05ML	Pre-Filled Syringe	2022/05/27	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Fylnetra	761084	001	351(k) Biosimilar	pegfilgrastim-pbbk	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2022/05/26	Kashiv BioSciences, LLC	Rx	Licensed	pegfilgrastim	Neulasta
Sucraid	020772	002	351(a)	sacrosidase	Solution For Oral	Oral	17,000IU/2ML (8,500IU/ML)		2022/05/25	QOL Medical, LLC	Rx	Licensed	N/A	N/A
Alymsys	761231	001	351(k) Biosimilar	bevacizumab-maly	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2022/04/13	Amneal Pharmaceuticals LLC	Rx	Licensed	bevacizumab	Avastin
Alymsys	761231	002	351(k) Biosimilar	bevacizumab-maly	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2022/04/13	Amneal Pharmaceuticals LLC	Rx	Licensed	bevacizumab	Avastin
Hyrimoz	761071	003	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	10MG/0.2ML	Pre-Filled Syringe	2022/03/28	Sandoz Inc.	Disc	Licensed	adalimumab	Humira
Cyltezo	761058	003	351(k) Interchangeable	adalimumab-adbm	Injection	Subcutaneous	10MG/0.2ML	Pre-Filled Syringe	2022/03/18	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
Opdualag	761234	001	351(a)	nivolumab and relatlimab-rmbw	Injection	Intravenous	240MG, 80MG/20ML (12MG, 4MG/ML)	Single-Dose Vial	2022/03/18	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Carvykti	125746	001	351(a)	ciltacabtagene autoleucel	For Injection	Intravenous	0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion	Bag	2022/02/28	Janssen Biotech, Inc.	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	-