Idacio® (adalimumab-aacf)

aBL 761255

Idacio® (adalimumab-aacf)

aBL 761255

U.S. License Holder:

Fresenius Kabi USA

Date of License:

December-13-2022

Last Update:

Sep-30-2024

approved_indications FDA-Approved Indications


IDACIO (adalimumab-aacf) 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_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Idacio® (Fresenius Kabi) (October-2020)

Biosimilars Approved In The E.U.

Idacio® (Fresenius Kabi) (April-2019)
Kromeya (adalimumab) (Fresenius Kabi) (April-2019)

Biosimilars Approved In Australia

Idacio® (Fresenius Kabi) (June-2020)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
10,155,039 (Stable Aqueous Formulations of Adalimumab)

Patent Owner
Coherus BioSciences, Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi Swissbiosim GmbH

§ 102 Challenge
N

§ 103 challenge
N

IPR Status
Challenges Include Written Description (Claims 1-12), Enablement (Claims 1-12), and Indefiniteness (Claims 1-12); PGR Not Instituted; Request for Rehearing of Institution Decision Denied

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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