Humira® (adalimumab)

BL 125057

Humira® (adalimumab)

BL 125057

U.S. License Holder:

AbbVie Inc.

Date of License:

December-31-2002

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


HUMIRA (adalimumab) 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;

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;

Pediatric Crohn's Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate;

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);

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): The treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older;

Uveitis (UV): The treatment of non-infectious intermediate, posterior and panuveitis in adults and pediatric patients 2 years of age and older.

approved_indications aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Approved by FDA

Amjevita: Amgen (September-2016) Cyltezo: Boehringer Ingelheim (August-2017) Hyrimoz: Sandoz (October-2018)

aBLA / 505(b)(2) Accepted by FDA

SB5 (Samsung Bioepis) (September-2018)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Amgevita / Solymbic (Amgen) (March-2017)
Cyltezo (Boehringer Ingelheim) (November-2017); Hyrimoz® (Sandoz) (July-2018)
Hulio® (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)
Imraldi (Samsung Bioepis) (August-2017)

Biosimilars Approved In Australia

Amgevita (Amgen) (November-2017)
Hadlima (Samsung Bioepis) (January-2018)

Biosimilars Approved In South Korea

SB5 (Samsung Bioepis) (September-2017)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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

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 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

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 Ongoing

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

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 Ongoing

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

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 Ongoing

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

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Boehringer Ingelheim Corp.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH and Co. KG; Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim USA Corp.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2362 (Consolidated with 17-2304)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Ongoing

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

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Boehringer Ingelheim Corp.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH and Co. KG; Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim USA Corp.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2363 (Consolidated with 17-2304)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Ongoing

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

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request For Rehearing Denied

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

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

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

Claim Types Challenged Under § 102
Formulation

§ 102 Challenge Instituted
N

§ 103 challenge
N

IPR Status
IPR Not Instituted

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

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

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

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

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

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

U.S. Patent No.
8,802,100 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz 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 No.
9,512,216 (Use of TNF-Alpha Inhibitor)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Federal Circuit Appeal(s)
18-2142

IPR Status
IPR Not Instituted; Request for Rehearing Denied; Federal Circuit Appeal Voluntarily Dismissed

U.S. Patent No.
8,911,737 (Methods of Administering Anti-TNF Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.; Abbott Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled while Request for Rehearing of Decision Denying Institution was Pending)

IPR Status
IPR Not Instituted; Request for Rehearing Terminated Due to Settlement

U.S. Patent No.
8,974,790 (Methods of Administering Anti-TNF Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.; Abbott Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled while Request for Rehearing of Decision Denying Institution was Pending)

IPR Status
IPR Not Instituted; Request for Rehearing Terminated Due to Settlement

U.S. Patent No.
9,090,689 (Use of TNF-Alpha Inhibitor for Treatment of Psoriasis)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

U.S. Patent No.
9,067,992 (Use of TNF-Alpha Inhibitor for Treatment of Psoriatic Arthritis)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled After Institution)

IPR Status
Terminated Due to Settlement After Institution

U.S. Patent No.
9,512,216 (Use of TNF-Alpha Inhibitor)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

Federal Circuit Appeal(s)
18-2143 (Consolidated with lead appeal 18-2142)

IPR Status
IPR Not Instituted; Federal Circuit Appeal Voluntarily Dismissed

U.S. Patent No.
9,187,559 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Sandoz Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
7,846,442 (Method of Treating Rheumatoid Arthritis with an Anti-TNF-Alpha Antibodies and Methotrexate)

Plaintiffs
Abbott Biotechnology Ltd.; Abbott Laboratories; AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Mathilda and Terence Kennedy Institute of Rheumatology Trust

Federal Circuit Appeal(s)
13-1545

Status
Case Terminated

BPCIA
N

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

BPCIA
Y

U.S. Patent Nos.
8,926,975 (Method of Treating Ankylosing Spondylitis) 9,018,361 (Isolation and Purification of Antibodies Using Protein A Affinity Chromatography) 9,090,867 (Fed-batch Method of Making Anti-TNF-Alpha Antibody) 9,096,666 (Purified Antibody Composition) 9,255,143 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,266,949 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,272,041 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders) 9,546,212 (Methods of Administering Anti-TNF Alpha Antibodies)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Boehringer Ingelheim Fremont, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals Inc.

Status
Case Ongoing

BPCIA
Y

U.S. Patent Nos.
7,070,775 (Recombinant A2-Specific TNF-Alpha Specific Antibodies) 7,276,239 ((Recombinant A2-Specific TNF-Alpha Specific Antibodies)

Plaintiffs
Centocor Ortho Biotech, Inc.; New York University

Defendants
Abbott Laboratories; Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd.

Status
Case Terminated

BPCIA
N

U.S. Patent Nos.
7,070,775 (Recombinant A2-Specific TNF-Alpha Specific Antibodies)

Plaintiffs
Centocor Ortho Biotech, Inc.; New York University

Defendants
Abbott Laboratories; Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd.

Status
Case Terminated

BPCIA
N

U.S. Patent Nos.
6,248,516 (Single Domain Ligands, Receptors Comprising said Ligands, Methods for their Production, and Use of said Ligands and Receptors)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
MedImmune Ltd.

Federal Circuit Appeal(s)
17-1689

Status
Case Dismissed; Federal Circuit Affirmed

BPCIA
N

U.S. Patent Nos.
9,187,559 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease) 9,750,808 (Formulation of Human Antibodies for Treating TNF-alpha Associated Disorders)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Status
Dismissed

BPCIA
Y

U.S. Patent Nos.
5,654,407 (Human Anti-TNF Antibodies)

Plaintiffs
Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd.; Abbott Laboratories

Defendants
Bayer Healthcare, LLC

Federal Circuit Appeal(s)
11-1205

Status
Case Terminated

BPCIA
N

U.S. Patent Nos.
5,654,407 (Human Anti-TNF Antibodies)

Plaintiffs
Bayer Healthcare, LLC

Defendants
Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd; Abbott Laboratories

Federal Circuit Appeal(s)
11-1205

Status
Case Terminated

BPCIA
N

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Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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