U.S. License Holder:

Samsung Bioepis

Date of License:

July-23-2019 (Low Concentr.), June-2024 (Interchangeable); August-17-2022 (High Concentr.), May-27-2

FDA-Approved Indications

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

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 rheumatoid arthritis;

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older;

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis;

Reducing signs and symptoms in adult patients with active ankylosing spondylitis;

Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older;

Treatment of moderately to severely active ulcerative colitis in adult patients;

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;

Treatment of moderate to severe hidradenitis suppurativa in adlut patients;

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)