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
Ennumo	761147	001	351(k) Biosimilar	pegfilgrastim-pccg	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2026/05/07	Accord BioPharma Inc.	Rx	Licensed	pegfilgrastim	Neulasta
Hadlima	761059	006	351(k) Interchangeable	adalimumab-bwwd	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2026/04/29	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Langlara	761412	001	351(k) Interchangeable	insulin glargine-aldy	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2026/04/29	Sunshine Lake Pharma Co., Ltd.	Rx	Licensed	insulin glargine	Lantus
Saphnelo	761451	001	351(a)	anifrolumab-fnia	Injection	Subcutaneous	120MG/0.8ML	Pre-Filled Syringe	2026/04/24	AstraZeneca AB	Rx	Licensed	N/A	N/A
Saphnelo	761451	002	351(a)	anifrolumab-fnia	Injection	Subcutaneous	120MG/0.8ML	Autoinjector	2026/04/24	AstraZeneca AB	Rx	Licensed	N/A	N/A
OTARMENI	125874	001	351(a)	lunsotogene parvec-cwha	Suspension	Intracochlear	3x10^13VG/ML	Single-Dose Vial	2026/04/23	Regeneron Pharmaceuticals, Inc.	Rx	Licensed
Thrombin-Jmi, Thrombocoll	102865	003	351(a)	Thrombin, Topical (Bovine)	Solution	Topical	20,000IU	Single-Dose Vial	2026/04/10	GenTrac, Inc.	Rx	Licensed
Thrombin-Jmi, Thrombocoll	102865	004	351(a)	Thrombin, Topical (Bovine)	Solution	Topical	5,000IU	Single-Dose Vial	2026/04/10	GenTrac, Inc.	Rx	Licensed
Ponlimsi	761385	001	351(k) Interchangeable	denosumab-adet	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2026/03/27	Teva Pharmaceuticals, Inc.	Rx	Licensed	denosumab	Prolia
kresladi	125806	001	351(a)	marnetegragene autotemcel	Suspension	Intravenous	0.34 to 6.1 × 10^6 cells/mL (including 0.32 to 6.1 × 10^6 CD34+ cells/mL)	Bag	2026/03/26	Rocket Pharmaceuticals Inc	Rx	Licensed
Awiqli	761326	001	351(a)	insulin icodec-abae	Injection	Subcutaneous	2,100UNITS/3ML (700UNITS/ML)	Autoinjector	2026/03/26	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Awiqli	761326	002	351(a)	insulin icodec-abae	Injection	Subcutaneous	1,050UNITS/1.5ML (700UNITS/ML)	Autoinjector	2026/03/26	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Awiqli	761326	003	351(a)	insulin icodec-abae	Injection	Subcutaneous	700UNITS/ML	Autoinjector	2026/03/26	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Avlayah	761485	001	351(a)	tividenofusp alfa-eknm	For Injection	Intravenous	150MG	Single-Dose Vial	2026/03/24	Denali Therapeutics Inc.	Rx	Licensed	N/A	N/A
Loargys	761211	001	351(a)	pegzilarginase-nbln	Injection	Intravenous, Subcutaneous	2MG/0.4ML	Single-Dose Vial	2026/02/23	Immedica Pharma AB	Rx	Licensed	N/A	N/A
Loargys	761211	002	351(a)	pegzilarginase-nbln	Injection	Intravenous, Subcutaneous	5MG/ML	Single-Dose Vial	2026/02/23	Immedica Pharma AB	Rx	Licensed	N/A	N/A
Rybrevant Faspro	761484	001	351(a)	amivantamab and hyaluronidase-lpuj	Injection	Subcutaneous	1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML)	Single-Dose Vial	2026/02/13	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Rybrevant Faspro	761484	002	351(a)	amivantamab and hyaluronidase-lpuj	Injection	Subcutaneous	2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML)	Single-Dose Vial	2026/02/13	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Rybrevant Faspro	761484	003	351(a)	amivantamab and hyaluronidase-lpuj	Injection	Subcutaneous	2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML)	Single-Dose Vial	2026/02/13	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Rybrevant Faspro	761484	004	351(a)	amivantamab and hyaluronidase-lpuj	Injection	Subcutaneous	3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML)	Single-Dose Vial	2026/02/13	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License 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	-