U.S. License Holder:

Mylan Pharms. Inc.

Date of License:

July-06-2020

FDA-Approved Indications

HULIO (adalimumab-fkjp) is a tumor necrosis factor (TNF)-blocker indicated for treatment of:

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): The 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

Hulio® (Viatris / Fujifilm Kyowa Kirin) (February-2021)

Biosimilars Approved In The E.U.

Hulio® (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)

Biosimilars Approved In Australia

Hulio (Alphapharm) (February-2021)

Biosimilars Approved In Japan

Adalimumab BS (Fujifilm Kyowa Kirin Biologics / Mylan) (June-2020)