Yusimry — Venable's BiologicsHQ

U.S. License Holder:

Coherus BioSciences, Inc.

Date of License:

December-17-2021

Last Update:

Nov-15-2024

FDA-Approved Indications

YUSIMRY (adalimumab-aqvh) 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.

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-00172

U.S. Patent No.
8,889,135 (Methods of Administering Anti-TNF-Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-5

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2304

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed (with U.S. as Intervenor, Appeal Dismissed for Coherus)

IPR2016-00188

U.S. Patent No.
9,017,680 (Methods of Administering Anti-TNF-Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-4

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2305 (Consolidated with 17-2304)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed (with U.S. as Intervenor, Appeal Dismissed for Coherus)

IPR2016-00189

U.S. Patent No.
9,073,987 (Methods of Administering Anti-TNF-Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-2

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2306 (Consolidated with 17-2304)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed (with U.S. as Intervenor, Appeal Dismissed for Coherus)

IPR2016-01018

U.S. Patent No.
9,114,166 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-4, 6-10, 13-16, 23-26, 28

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request For Rehearing Denied

IPR2017-00822

U.S. Patent No.
9,085,619 (Anti-TNF Antibody Formulations)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
Y: Claims 16-19, 24-30

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
N

§ 103 challenge
Y: Claims 16-19, 24-30

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-00823

U.S. Patent No.
9,085,619 (Anti-TNF Antibody Formulations)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
Y: Claims 16-19, 24-30

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
N

§ 103 challenge
N

IPR Status
IPR Not Instituted

IPR2017-00826 / IPR2017-01008

U.S. Patent No.
9,085,619 (Anti-TNF Antibody Formulations)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 16-19, 24-30

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR2017-01008 Replaced IPR2017-00826 (Terminated April 11, 2017); IPR Not Instituted

IPR2017-00827 / IPR2017-01009

U.S. Patent No.
9,085,619 (Anti-TNF Antibody Formulations)

Patent Owner
AbbVie Biotechnology Ltd.; AbbVie Inc.

Petitioner(s)
Coherus BioSciences Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 16-19, 24-30

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR2017-01009 Replaced IPR2017-00827 (Terminated April 11, 2017); IPR Not Instituted

PGR2019-00064

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

U.S. Patent Litigations

PACER

Case No(s):

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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Yusimry (adalimumab-aqvh)

Yusimry (adalimumab-aqvh)

FDA-Approved Indications

Inter Partes Review Proceedings

IPR Case No(s):

IPR2016-00172

IPR2016-00188

IPR2016-00189

IPR2016-01018

IPR2017-00822

IPR2017-00823

IPR2017-00826 / IPR2017-01008

IPR2017-00827 / IPR2017-01009

PGR2019-00064

U.S. Patent Litigations

Case No(s):

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

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