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
Imuldosa	761364	003	351(k) Biosimilar	ustekinumab-srlf	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/10/10	Accord BioPharma Inc.	Rx	Licensed	ustekinumab	Stelara
Otulfi	761379	001	351(k) Interchangeable	ustekinumab-aauz	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2024/09/27	Fresenius Kabi USA, LLC	Rx	Licensed	ustekinumab	Stelara
Otulfi	761379	002	351(k) Interchangeable	ustekinumab-aauz	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/09/27	Fresenius Kabi USA, LLC	Rx	Licensed	ustekinumab	Stelara
Otulfi	761379	003	351(k) Interchangeable	ustekinumab-aauz	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/09/27	Fresenius Kabi USA, LLC	Rx	Licensed	ustekinumab	Stelara
Ebglyss	761306	001	351(a)	lebrikizumab-lbkz	Injection	Subcutaneous	250MG/2ML	Autoinjector	2024/09/13	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Ebglyss	761306	002	351(a)	lebrikizumab-lbkz	Injection	Subcutaneous	250MG/2ML	Pre-Filled Syringe	2024/09/13	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Ocrevus Zunovo	761371	001	351(a)	ocrelizumab and hyaluronidase-ocsq	Injection	Subcutaneous	920MG/23ML; 23,000UNITS/23ML (40MG/1,000UNITS/ML)	Single-Dose Vial	2024/09/13	Genentech, Inc.	Rx	Licensed	N/A	N/A
Tecentriq Hybreza	761347	001	351(a)	atezolizumab and hyaluronidase-tqjs	Injection	Subcutaneous	1,875MG/15ML; 30,000UNITS/15ML (125MG/2,000UNITS/ML)	Single-Dose Vial	2024/09/12	Genentech, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	003	351(a)	guselkumab	Injection	Subcutaneous	200MG/2ML (100MG/ML)	Autoinjector	2024/09/11	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	004	351(a)	guselkumab	Injection	Subcutaneous	200MG/2ML (100MG/ML)	Pre-Filled Syringe	2024/09/11	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	005	351(a)	guselkumab	Injection	Intravenous	200MG/20ML (10MG/ML)	Single-Dose Vial	2024/09/11	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Hercessi	761346	002	351(k) Biosimilar	trastuzumab-strf	For Injection	Intravenous	420MG	Multi-Dose Vial	2024/09/06	Accord BioPharma Inc.	Rx	Licensed	trastuzumab	Herceptin
Pavblu	761298	001	351(k) Biosimilar	aflibercept-ayyh	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2024/08/23	Amgen Inc.	Rx	Licensed	aflibercept	Eylea
Pavblu	761298	002	351(k) Biosimilar	aflibercept-ayyh	Injection	Intravitreal	2MG/0.05ML	Pre-Filled Syringe	2024/08/23	Amgen Inc.	Rx	Licensed	aflibercept	Eylea
Taltz	125521	003	351(a)	ixekizumab	Injection	Subcutaneous	40MG/0.5ML	Pre-Filled Syringe	2024/08/20	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Taltz	125521	004	351(a)	ixekizumab	Injection	Subcutaneous	20MG/0.25ML	Pre-Filled Syringe	2024/08/20	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Niktimvo	761411	001	351(a)	axatilimab-csfr	Injection	Intravenous	50MG/ML	Single-Dose Vial	2024/08/14	Incyte Corporation	Rx	Licensed	N/A	N/A
Nemluvio	761390	001	351(a)	nemolizumab-ilto	For Injection	Subcutaneous	30MG	Autoinjector	2024/08/12	Galderma Laboratories, L.P.	Rx	Licensed	N/A	N/A
Zarxio	125553	003	351(k) Biosimilar	filgrastim-sndz	Injection	Intravenous, Subcutaneous	300MCG/ML	Single-Dose Vial	2024/08/09	Sandoz Inc.	Disc	Licensed	filgrastim	Neupogen
Zarxio	125553	004	351(k) Biosimilar	filgrastim-sndz	Injection	Intravenous, Subcutaneous	480MCG/1.6ML (300MCG/ML)	Single-Dose Vial	2024/08/09	Sandoz Inc.	Disc	Licensed	filgrastim	Neupogen

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	-