Unbranded Biologic Drugs

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FDA Unbranded Biologic Drugs

List of unbranded biologics being sold as authorized biosimilars

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Applicant	Unbranded Labeller	Biologic Ingredient	Dosage Form	BLA	NDC Stem	Launch Date
Smith & Nephew, Inc.	SMITH & NEPHEW, INC	collagenase	Ointment	101995	50484-010	2006-10-18
Boehringer Ingelheim Pharmaceuticals, Inc.	Boehringer Ingelheim Pharmaceuticals, Inc.	adalimumab-adbm	Injection	761058	0597-0555	2023-10-01
Alvotech Usa Inc.	Teva Pharmaceuticals USA, Inc.	ustekinumab-aekn	Injection	761343	51759-709	2025-06-02
Novo Nordisk Inc.	Novo Nordisk Pharma, Inc.	insulin degludec	Injection	203314	73070-400	2022-07-01
Samsung Bioepis Co., Ltd.	Cordavis Limited	adalimumab-bwwd	Injection	761059	83457-187	2025-12-12
>Applicant	>Unbranded Labeller	>Biologic Ingredient	>Dosage Form	>BLA	>NDC Stem	>Launch Date

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