U.S. License Holder:

Samsung Bioepis

Date of License:

July-23-2019 (Low Concentration); August-17-2022 (High Concentration); sBLA for interchangeability p

FDA-Approved Indications

HADLIMA (adalimumab-bwwd) is a tumor necrosis factor (TNF)-blocker indicated for:

Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA;

Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older;

Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA;

Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS;

Crohn’s Disease (CD): Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older;

Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients;

Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate;

Hidradenitis Suppurativa (HS): Treatment of moderate to severe hidradenitis suppurativa in adult patients;

Uveitis (UV): Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Hadlima (Samsung Bioepis) (May-2018, high-concentration January-2023)

Biosimilars Approved In The E.U.

Imraldi (Samsung Bioepis) (August-2017)

Biosimilars Approved In Australia

Hadlima (Samsung Bioepis) (January-2018)

Biosimilars Approved In South Korea

Adalloce (Samsung Bioepis) (September-2017, high-concentration January-2023)