Hadlima (adalimumab-bwwd)

aBL 761059

Hadlima (adalimumab-bwwd)

aBL 761059

U.S. License Holder:

Samsung Bioepis

Date of License:

July-23-2019 (Low Concentration); August-17-2022 (High Concentration)

Last Update:

May-23-2023

approved_indications 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.

approved_indications 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)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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