Amjevita — Venable's BiologicsHQ

U.S. License Holder:

Amgen, Inc.

Date of License:

September-23-2016

Last Update:

January-23-2023

FDA-Approved Indications

AMJEVITA (adalimumab-atto) 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.

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Amgevita (Amgen) (November-2020)

Biosimilars Approved In The E.U.

Amgevita (Amgen) (March-2017)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2015-01514

U.S. Patent No.
8,916,157 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Amgen Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2015-01517

U.S. Patent No.
8,916,158 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Amgen Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent Litigations

PACER

Case No(s):

1:16-cv-00666 (D. Del.)

U.S. Patent Nos.
8,663,945 (Methods of Producing Anti-TNF-Alpha Antibodies in Mammalian Cell Culture) 8,911,964 (Fed-Batch Method of Making Human Anti-TNF-Alpha Antibody) 8,916,157 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders) 8,961,973 (Multiple-Variable Dose Regimen for Treating TNF-Alpha-Related Disorders) 8,986,693 (Use of TNF-Alpha Inhibitor for Treatment of Psoriasis) 9,096,666 (Purified Antibody Composition) 9,220,781 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders) 9,272,041 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders) 9,359,434 (Cell Culture Methods to Reduce Acidic Species) 9,365,645 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Amgen, Inc.; Amgen Manufacturing, Ltd.

Status
Dismissed due to Settlement

BPCIA
Y

1:19-cv-00139 (D. Del.)

U.S. Patent Nos.
10,155,039 (Stable Aqueous Formulations of Adalimumab) 10,159,732 (Stable Aqueous Formulations of Adalimumab) 10,159,733 (Stable Aqueous Formulations of Adalimumab) 10,207,000 (Stable Aqueous Formulations of Adalimumab)

Plaintiffs
Coherus Biosciences, Inc.

Defendants
Amgen Inc.

Status
Stipulated Dismissal

BPCIA
N

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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Amjevita (adalimumab-atto)