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
Omlyclo	761399	003	351(k) Interchangeable	omalizumab-igec	Injection	Subcutaneous	300MG/2ML (150MG/ML)	Pre-Filled Syringe	2025/12/01	CELLTRION, Inc.	Rx	Licensed	omalizumab	Xolair
Armlupeg	761212	001	351(k) Biosimilar	pegfilgrastim-unne	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2025/11/28	Lupin Limited (Biotech Division)	Rx	Licensed	pegfilgrastim	Neulasta
Voyxact	761434	001	351(a)	sibeprenlimab-szsi	Injection	Subcutaneous	400MG/2ML (200MG/ML)	Pre-Filled Syringe	2025/11/25	Otsuka Pharmaceutical Company, Ltd.	Rx	Licensed	N/A	N/A
ITVISMA	125856	001	351(a)	onasemnogene abeparvovec-brve	Injection	Intrathecal	4x10^13VG/ML	Single-Dose Vial	2025/11/24	Novartis Gene Therapies, Inc.	Rx	Licensed		N/A
Opdivo Qvantig	761381	002	351(a)	nivolumab and hyaluronidase-nvhy	Injection	Subcutaneous	300MG/2.5ML;5,000UNITS/2.5ML (120MG/2,000UNITS/ML)	Single-Dose Vial	2025/11/24	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Poherdy	761450	001	351(k) Interchangeable	pertuzumab-dpzb	Injection	Intravenous	420MG/14ML (30MG/ML)	Single-Dose Vial	2025/11/13	Shanghai Henlius Biotech, Inc.	Rx	Licensed	pertuzumab	Perjeta
Osvyrti	761424	001	351(k) Interchangeable	denosumab-desu	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/10/29	Accord BioPharma Inc.	Rx	Licensed	denosumab	Prolia
Jubereq	761424	002	351(k) Interchangeable	denosumab-desu	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/10/29	Accord BioPharma Inc.	Rx	Licensed	denosumab	Xgeva
Blenrep	761440	001	351(a)	belantamab mafodotin-blmf	For Injection	Intravenous	70MG	Single-Dose Vial	2025/10/23	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Eydenzelt	761377	001	351(k) Biosimilar	aflibercept-boav	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2025/10/02	CELLTRION, Inc.	Rx	Licensed	aflibercept	Eylea
Eydenzelt	761377	002	351(k) Biosimilar	aflibercept-boav	Injection	Intravitreal	2MG/0.05ML	Pre-Filled Syringe	2025/10/02	CELLTRION, Inc.	Rx	Licensed	aflibercept	Eylea
QIVIGY	125822	001	351(a)	Immune Globulin Intravenous, Human-kthm, 10% Solution	Solution	Intravenous	5G/50ML	Single-Dose Vial	2025/09/26	Kedrion, S.p.A.	Rx	Licensed	N/A
QIVIGY	125822	002	351(a)	Immune Globulin Intravenous, Human-kthm, 10% Solution	Solution	Intravenous	10G/100ML	Single-Dose Vial	2025/09/26	Kedrion, S.p.A.	Rx	Licensed	N/A
Enoby	761439	001	351(k) Interchangeable	denosumab-qbde	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/09/26	Hikma Pharmaceuticals USA Inc.	Rx	Licensed	denosumab	Prolia
Xtrenbo	761439	002	351(k) Interchangeable	denosumab-qbde	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/09/26	Hikma Pharmaceuticals USA Inc.	Rx	Licensed	denosumab	Xgeva
Keytruda Qlex	761467	001	351(a)	pembrolizumab and berahyaluronidase alfa-pmph	Injection	Subcutaneous	395MG/2.4ML; 4,800UNITS/2.4ML (165MG/2,000UNITS/ML)	Single-Dose Vial	2025/09/19	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Keytruda Qlex	761467	002	351(a)	pembrolizumab and berahyaluronidase alfa-pmph	Injection	Subcutaneous	790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML)	Single-Dose Vial	2025/09/19	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Bosaya	761436	001	351(k) Interchangeable	denosumab-kyqq	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/09/16	Biocon Biologics Inc.	Rx	Licensed	denosumab	Prolia
Aukelso	761436	002	351(k) Interchangeable	denosumab-kyqq	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/09/16	Biocon Biologics Inc.	Rx	Licensed	denosumab	Xgeva
Skyrizi	761105	007	351(a)	risankizumab-rzaa	Injection	Subcutaneous	180MG/1.2ML (150MG/ML)	Pre-Filled Syringe	2025/09/03	AbbVie 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	-