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FDA BLA · BLA761059

ADALIMUMAB-BWWD

Sponsor: SAMSUNG BIOEPIS CO LTD

APPLICATION
BLA761059
TYPE
BLA
ORIGINAL APPROVAL
2019-07-23
LATEST ACTION
2026-04-29
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HADLIMAPrescription
ADALIMUMAB-BWWD 40MG/0.8ML · INJECTABLE · INJECTION

Approval history

2026-04-29Manufacturing (CMC) · Supplement 36 — Label ↗AP
2025-10-17Manufacturing (CMC) · Supplement 32 — Label ↗AP
2025-06-23Labeling · Supplement 30 · standard — Label ↗AP
2025-05-21Supplement · Supplement 25 — Letter ↗AP
2025-05-21Supplement · Supplement 26 — Letter ↗AP
2024-06-28BIOSIMILAR · Supplement 18 · standard — Label ↗AP
2023-07-11Efficacy · Supplement 8 · standard — Letter ↗AP
2023-06-26Efficacy · Supplement 6 · standard — Label ↗AP
2023-04-26Labeling · Supplement 13 · standard — Label ↗AP
2022-12-23Labeling · Supplement 7 · standard — Letter ↗AP
2022-08-15Efficacy · Supplement 5 · standard — Letter ↗AP
2022-06-17Efficacy · Supplement 4 · standard — Letter ↗AP
2019-07-23Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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