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
Tofidence	761354	001	351(k) Biosimilar	tocilizumab-bavi	Injection	Intravenous	80MG/4ML (20MG/ML)	Single-Dose Vial	2023/09/29	Biogen MA Inc.	Rx	Licensed	tocilizumab	Actemra
Tofidence	761354	002	351(k) Biosimilar	tocilizumab-bavi	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2023/09/29	Biogen MA Inc.	Rx	Licensed	tocilizumab	Actemra
Tofidence	761354	003	351(k) Biosimilar	tocilizumab-bavi	Injection	Intravenous	400MG/20ML (20MG/ML)	Single-Dose Vial	2023/09/29	Biogen MA Inc.	Rx	Licensed	tocilizumab	Actemra
Pombiliti	761204	001	351(a)	cipaglucosidase alfa-atga	Injection	Intravenous	105MG	Single-Dose Vial	2023/09/28	Amicus Therapeutics US, LLC	Rx	Licensed	N/A	N/A
Entyvio	761133	001	351(a)	vedolizumab	Injection	Subcutaneous	108MG/0.68ML	Pre-Filled Syringe	2023/09/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Entyvio Pen	761133	002	351(a)	vedolizumab	Injection	Subcutaneous	108MG/0.68ML	Autoinjector	2023/09/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Comirnaty	125742	002	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	30UG	Pre-Filled Syringe	2023/09/11	BioNTech Manufacturing GmbH	Disc	Licensed	N/A	N/A
Comirnaty	125742	003	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	30UG	Single-Dose Vial	2023/09/11	BioNTech Manufacturing GmbH	Rx	Licensed	N/A	N/A
Spikevax	125752	002	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	50UG/0.5mL	Pre-Filled Syringe	2023/09/11	ModernaTX, Inc.	Rx	Licensed	N/A	N/A
Spikevax	125752	003	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	50UG	Single-Dose Vial	2023/09/11	ModernaTX, Inc.	Disc	Licensed	N/A	N/A
Spikevax	125752	004	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	50UG	Multi-Dose Vial	2023/09/11	ModernaTX, Inc.	Disc	Licensed	N/A	N/A
Tyruko	761322	001	351(k) Biosimilar	natalizumab-sztn	Injection	Intravenous	300MG/15ML (20MG/ML)	Single-Dose Vial	2023/08/24	Sandoz Inc.	Rx	Licensed	natalizumab	Tysabri
Veopoz	761339	001	351(a)	pozelimab-bbfg	Injection	Intravenous, Subcutaneous	400MG/2ML (200MG/ML)	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Eylea HD	761355	001	351(a)	aflibercept	Injection	Intravitreal	8MG/0.07ML	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	004	351(a)	omalizumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	005	351(a)	omalizumab	Injection	Subcutaneous	75MG/0.5ML	Autoinjector	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	006	351(a)	omalizumab	Injection	Subcutaneous	150MG/ML	Autoinjector	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	007	351(a)	omalizumab	Injection	Subcutaneous	300MG/2ML	Autoinjector	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Amjevita	761024	005	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	006	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira

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	-