U.S. License Holder:

Mylan Pharms. Inc.

Date of License:

July-06-2020

FDA-Approved Indications

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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 4 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;

Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products;

Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers;

Plaque Psoriasis (Ps): The treatment of adult patients with mode rate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Approved Foreign Follow-On Biologics / Biosimilars

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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 Japan

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