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Humira biosimilars

Complete Humira (ADALIMUMAB) biosimilar landscape: 19 approved biosimilars, 0 filed, 13 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

19 approved 0 filed 13 Phase 3 All key patents expired

About Humira

Humira (ADALIMUMAB) — originally marketed by AbbVie. Class: TNF blocker. Target: Tumor Necrosis Factor-alpha (TNF-alpha). Area: Oncology. First approved 2002-01-01.

Approved biosimilars (19)

BiosimilarSponsorPhaseFirst approvalCountry
Abrilada AbbVie marketed 2002-01-01
YUFLYMA CELLTRION marketed
Adalimumab with methotrexate Pfizer marketed
SIMLANDI ALVOTECH USA INC marketed
HADLIMA SAMSUNG BIOEPIS CO LTD marketed
adalimumab, plus prednisone Fondazione IRCCS Policlinico San Matteo di Pavia marketed
Adalimumab (ADA) JHSPH Center for Clinical Trials marketed
Adalimumab treatment arm Medical University of Vienna marketed
Adalimumab, etanercept, infliximab University of Padova marketed
Adalimumab and its biosimilars Hanyang University Seoul Hospital marketed
HULIO MYLAN PHARMS INC marketed
YUSIMRY COHERUS BIOSCIENCES INC marketed
Adalimumab plus different doses of oral glucocorticosteroid Peking Union Medical College Hospital marketed
CYLTEZO BOEHRINGER INGELHEIM marketed
Adalimumab (Humira) Tufts Medical Center marketed
HYRIMOZ SANDOZ INC marketed
SB5 (Adalimumab Biosimilar) Samsung Bioepis Co., Ltd. marketed
IDACIO FRESENIUS KABI USA marketed
Adalimumab Ab Qilu Hospital of Shandong University marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (13)

BiosimilarSponsorPhaseFirst approvalCountry
Adalimumab - GP2017 Sandoz phase 3
adalimumab (D2E7) Abbott phase 3
MYL-1401A (Adalimumab) Mylan Inc. phase 3
CT-P17 SC AI (adalimumab) Celltrion phase 3
Adalimumab+Methotrexate Hospital San Carlos, Madrid phase 3
Adalimumab subcutaneous injection Biocad phase 3
Adalimumab biosimilar Alvotech Swiss AG phase 3
Adalimumab - US licensed Humira Sandoz phase 3
Adalimumab Every Week Innovaderm Research Inc. phase 3
Adalimumab (40 mg) Janssen Scientific Affairs, LLC phase 3
GP2017 Adalimumab Sandoz phase 3
Adalimumab every other week Innovaderm Research Inc. phase 3
Adalimumab originator Alvotech Swiss AG phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Humira or any of its biosimilars:

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