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
Opuviz	761350	001	351(k) Interchangeable	aflibercept-yszy	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2024/05/20	Samsung Bioepis Co., Ltd.	Rx	Licensed	aflibercept	Eylea
Elfabrio	761161	002	351(a)	pegunigalsidase alfa-iwxj	Injection	Intravenous	5MG/2.5ML	Single-Dose Vial	2024/05/17	Chiesi Farmaceutici S.p.A.	Rx	Licensed	N/A	N/A
Imdelltra	761344	001	351(a)	tarlatamab-dlle	Injection	Intravenous	1MG	Single-Dose Vial	2024/05/16	Amgen Inc.	Rx	Licensed	N/A	N/A
Imdelltra	761344	002	351(a)	tarlatamab-dlle	Injection	Intravenous	10MG	Single-Dose Vial	2024/05/16	Amgen Inc.	Rx	Licensed	N/A	N/A
Eticovo	761066	003	351(k) Biosimilar	etanercept-ykro	Injection	Subcutaneous	50MG/ML	Autoinjector	2024/05/03	Samsung Bioepis Co., Ltd.	Disc	Licensed	etanercept	Enbrel
Cyltezo	761058	005	351(k) Interchangeable	adalimumab-adbm	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2024/04/30	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
Cyltezo	761058	006	351(k) Interchangeable	adalimumab-adbm	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2024/04/30	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
BEQVEZ	125786	001	351(a)	fidanacogene elaparvovec-dzkt	Suspension	Intravenous	1x E13 VG/ML	Single-Dose Vial	2024/04/25	Pfizer Inc.	Disc	Voluntarily Revoked	N/A	N/A
Hercessi	761346	001	351(k) Biosimilar	trastuzumab-strf	For Injection	Intravenous	150MG	Single-Dose Vial	2024/04/25	Accord BioPharma Inc.	Rx	Licensed	trastuzumab	Herceptin
Anktiva	761336	001	351(a)	nogapendekin alfa inbakicept-pmln	Solution	Intravesical	400MCG/0.4ML	Single-Dose Vial	2024/04/22	Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.	Rx	Licensed	N/A	N/A
Selarsdi	761343	001	351(k) Interchangeable	ustekinumab-aekn	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2024/04/16	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara
Selarsdi	761343	002	351(k) Interchangeable	ustekinumab-aekn	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/04/16	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara
Fasenra	761070	003	351(a)	benralizumab	Injection	Subcutaneous	10MG/0.5ML	Pre-Filled Syringe	2024/04/05	AstraZeneca AB	Rx	Licensed	N/A	N/A
Abecma	125736	002	351(a)	idecabtagene vicleucel	Suspension	Intravenous	300 to 510 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS	Bag	2024/04/04	Celgene Corporation, a Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Winrevair	761363	001	351(a)	sotatercept-csrk	For Injection	Subcutaneous	45MG	Single-Dose Vial	2024/03/26	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Winrevair	761363	002	351(a)	sotatercept-csrk	For Injection	Subcutaneous	60MG	Single-Dose Vial	2024/03/26	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Lenmeldy	125758	001	351(a)	atidarsagene autotemcel	Suspension	Intravenous	2 x 10^6 to 11.8 x 10^6CELL/ML	Bag	2024/03/18	Orchard Therapeutics (Europe) Ltd.	Rx	Licensed	N/A	N/A
Spevigo	761244	002	351(a)	spesolimab-sbzo	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2024/03/18	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Tevimbra	761232	001	351(a)	tislelizumab-jsgr	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2024/03/13	BeiGene USA, Inc.	Rx	Licensed	N/A	N/A
Tyenne	761275	001	351(k) Biosimilar	tocilizumab-aazg	Injection	Intravenous	80MG/4ML (20MG/ML)	Single-Dose Vial	2024/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra

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	-