← FDA DRUG APPROVALS

FDA BLA · BLA761216

YUSIMRY

adalimumab-aqvh

Sponsor: COHERUS BIOSCIENCES INC

APPLICATION
BLA761216
TYPE
BLA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2025-11-10
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

YUSIMRYPrescription
ADALIMUMAB-AQVH 40MG · INJECTABLE · INJECTION

Approval history

2025-11-10BIOSIMILAR · Supplement 7 — Label ↗AP
2023-09-13Bioequivalence · Supplement 4 · unknown — Letter ↗AP
2023-03-31UNKNOWN · Supplement 3 · standard — Label ↗AP
2023-02-27Efficacy · Supplement 1 · standard — Label ↗AP
2021-12-17Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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