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
Enzeevu	761382	001	351(k) Biosimilar	aflibercept-abzv	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2024/08/09	Sandoz Inc.	Rx	Licensed	aflibercept	Eylea
Enzeevu	761382	002	351(k) Biosimilar	aflibercept-abzv	Injection	Intravitreal	2MG/0.05ML	Pre-Filled Syringe	2024/08/09	Sandoz Inc.	Rx	Licensed	aflibercept	Eylea
Lymphir	761312	001	351(a)	denileukin diftitox-cxdl	For Injection	Intravenous	300MCG	Single-Dose Vial	2024/08/07	Citius Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
tecelra	125789	001	351(a)	afamitresgene autoleucel	Suspension	Intravenous	2.68 x 10^9 to 10 x 10^9 CELL/ML	Bag	2024/08/01	Adaptimmune LLC	Rx	Licensed	N/A	N/A
Epysqli	761340	001	351(k) Biosimilar	eculizumab-aagh	Injection	Intravenous	300MG/30ML (10MG/ML)	Single-Dose Vial	2024/07/19	Samsung Bioepis Co., Ltd.	Rx	Licensed	eculizumab	Soliris
Vabysmo	761235	002	351(a)	faricimab-svoa	Injection	Intravitreal	6MG/0.05ML (120MG/ML)	Pre-Filled Syringe	2024/07/09	Genentech, Inc.	Rx	Licensed	N/A	N/A
Kisunla	761248	001	351(a)	donanemab-azbt	Injection	Intravenous	350MG/20ML (17.5MG/ML)	Single-Dose Vial	2024/07/02	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Nypozi	761126	001	351(k) Biosimilar	filgrastim-txid	Injection	Intravenous, Subcutaneous	300MCG/0.5ML	Pre-Filled Syringe	2024/06/28	Tanvex BioPharma USA, Inc.	Rx	Licensed	filgrastim	Neupogen
Nypozi	761126	002	351(k) Biosimilar	filgrastim-txid	Injection	Intravenous, Subcutaneous	480MCG/0.8ML	Pre-Filled Syringe	2024/06/28	Tanvex BioPharma USA, Inc.	Rx	Licensed	filgrastim	Neupogen
Pyzchiva	761373	001	351(k) Interchangeable	ustekinumab-ttwe	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2024/06/28	Samsung Bioepis Co., Ltd.	Rx	Licensed	ustekinumab	Stelara
Pyzchiva	761373	002	351(k) Interchangeable	ustekinumab-ttwe	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/06/28	Samsung Bioepis Co., Ltd.	Rx	Licensed	ustekinumab	Stelara
Ahzantive	761378	001	351(k) Biosimilar	aflibercept-mrbb	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2024/06/28	Formycon AG	Rx	Licensed	aflibercept	Eylea
Pyzchiva	761425	001	351(k) Interchangeable	ustekinumab-ttwe	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/06/28	Samsung Bioepis Co., Ltd.	Rx	Licensed	ustekinumab	Stelara
Simlandi	761299	002	351(k) Interchangeable	adalimumab-ryvk	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2024/06/26	Alvotech USA Inc.	Rx	Licensed	adalimumab	Humira
Simlandi	761299	003	351(k) Interchangeable	adalimumab-ryvk	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2024/06/26	Alvotech USA Inc.	Rx	Licensed	adalimumab	Humira
Simlandi	761299	004	351(k) Interchangeable	adalimumab-ryvk	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2024/06/26	Alvotech USA Inc.	Rx	Licensed	adalimumab	Humira
Sevenfact	125641	003	351(a)	coagulation factor VIIa (recombinant)-jncw	Injection	Intravenous	2MG	Single-Dose Vial	2024/06/20	Laboratoire Francais du Fractionnement et des Biotechnologies S.A.	Rx	Licensed
Piasky	761388	001	351(a)	crovalimab-akkz	Injection	Intravenous, Subcutaneous	340MG/2ML (170MG/ML)	Single-Dose Vial	2024/06/20	Genentech, Inc.	Rx	Licensed	N/A	N/A
CAPVAXIVE	125814	001	351(a)	Pneumococcal 21-valent Conjugate Vaccine	Injection	Intramuscular	84UG/.5ML	Pre-Filled Syringe	2024/06/17	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Rystiggo	761286	002	351(a)	rozanolixizumab-noli	Injection	Subcutaneous	420MG/3ML (140MG/ML)	Single-Dose Vial	2024/06/14	UCB, 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	-