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
Halozyme Therapeutics, Inc.	HF Acquisition Co LLC, DBA HealthFirst	hyaluronidase human	Injection	021859	51662-1555	2021-06-04
Boehringer Ingelheim Pharmaceuticals, Inc.	QUALLENT PHARMACEUTICALS HEALTH LLC	adalimumab-adbm	Injection	761058	82009-150	2024-04-30
Novo Nordisk Inc.	REMEDYREPACK INC.	insulin aspart	Injection	020986	70518-3865	2023-09-18
Biocon Biologics Inc.	Mylan Specialty L.P.	adalimumab-fkjp	Injection	761154	49502-417	2023-07-02
Boehringer Ingelheim Pharmaceuticals, Inc.	Boehringer Ingelheim Pharmaceuticals, Inc.	adalimumab-adbm	Injection	761058	0597-0575	2024-04-30
>Applicant	>Unbranded Labeller	>Biologic Ingredient	>Dosage Form	>BLA	>NDC Stem	>Launch Date

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