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
Bimzelx	761151	1	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	160MG/ML	Pre-Filled Syringe	2023/10/17	UCB, Inc.	Rx	Licensed
Bimzelx	761151	2	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	160MG/ML	Autoinjector	2023/10/17	UCB, Inc.	Rx	Licensed
Cosentyx	761349	1	351(a)	secukinumab	Injection	Intravenous	125MG/5ML	Single-Dose Vial	2023/10/06	Novartis Pharmaceuticals Corporation	Rx	Licensed
Yuflyma	761219	3	351(k) Biosimilar	adalimumab-aaty	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2023/09/29	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
Yuflyma	761219	4	351(k) Biosimilar	adalimumab-aaty	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2023/09/29	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
Yuflyma	761219	5	351(k) Biosimilar	adalimumab-aaty	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/09/29	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
Tofidence	761354	1	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	2	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	3	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	1	351(a)	cipaglucosidase alfa-atga	Injection	Intravenous	105MG	Single-Dose Vial	2023/09/28	Amicus Therapeutics US, LLC	Rx	Licensed
Entyvio	761133	1	351(a)	vedolizumab	Injection	Subcutaneous	108MG/0.68ML	Pre-Filled Syringe	2023/09/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Entyvio Pen	761133	2	351(a)	vedolizumab	Injection	Subcutaneous	108MG/0.68ML	Autoinjector	2023/09/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Comirnaty	125742	2	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	30UG	Pre-Filled Syringe	2023/09/11	BioNTech Manufacturing GmbH	Rx	Licensed
Comirnaty	125742	3	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	30UG	Single-Dose Vial	2023/09/11	BioNTech Manufacturing GmbH	Rx	Licensed
Spikevax	125752	2	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	50UG	Pre-Filled Syringe	2023/09/11	ModernaTX, Inc.	Rx	Licensed
Spikevax	125752	3	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	50UG	Single-Dose Vial	2023/09/11	ModernaTX, Inc.	Rx	Licensed
Spikevax	125752	4	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	50UG	Multi-Dose Vial	2023/09/11	ModernaTX, Inc.	Rx	Licensed
Tyruko	761322	1	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	1	351(a)	pozelimab-bbfg	Injection	Intravenous, Subcutaneous	400MG/2ML (200MG/ML)	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed
Eylea HD	761355	1	351(a)	aflibercept	Injection	Intravitreal	8MG/0.07ML	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed

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	-