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
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) Biosimilar	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) Biosimilar	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) Biosimilar	denosumab-kyqq	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/09/16	Biocon Biologics Inc.	Rx	Licensed	denosumab	Prolia
Aukelso	761436	002	351(k) Biosimilar	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
Krystexxa	125293	002	351(a)	pegloticase	Injection	Intravenous	8MG/50ML (0.16MG/ML)	Single-Dose Vial	2025/08/29	Horizon Therapeutics Ireland DAC	Rx	Licensed	N/A	N/A
Leqembi IQLIK	761375	001	351(a)	lecanemab-irmb	Injection	Subcutaneous	360MG/1.8ML (200MG/ML)	Autoinjector	2025/08/29	Eisai, Incorporated	Rx	Licensed	N/A	N/A
Bildyos	761444	001	351(k) Biosimilar	denosumab-nxxp	Injection	Subcutaneous	60MG/ML	Single-Dose Vial	2025/08/29	Shanghai Henlius Biotech, Inc.	Rx	Licensed	denosumab	Prolia
Bildyos	761444	002	351(k) Biosimilar	denosumab-nxxp	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/08/29	Shanghai Henlius Biotech, Inc.	Rx	Licensed	denosumab	Prolia
Bilprevda	761444	003	351(k) Biosimilar	denosumab-nxxp	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/08/29	Shanghai Henlius Biotech, Inc.	Rx	Licensed	denosumab	Xgeva
Comirnaty	125742	004	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	10UG	Single-Dose Vial	2025/08/27	BioNTech Manufacturing GmbH	Rx	Licensed	N/A	N/A
PAPZIMEOS	125832	001	351(a)	PAPZIMEOS	For Injection	Subcutaneous	5x10^11PARTICLE UNITS	Single-Dose Vial	2025/08/14	Precigen, Inc.	Rx	Licensed	N/A	N/A
Skytrofa	761177	010	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	0.7MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	011	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	1.4MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	012	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	1.8MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	013	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	2.1MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	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	-