Humira® (adalimumab)

BL 125057

Humira® (adalimumab)

BL 125057

U.S. License Holder:

AbbVie Inc.

Date of License:

December-31-2002

Last Update:

Nov-15-2024

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;

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 adults and pediatric patients 5 years of age and older;

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 patients 12 years of age and older;

Uveitis (UV): 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; Interchangeable October-2021; High-Concentration April-2024) Hyrimoz®: Sandoz (October-2018; High Concentration March-2023; Interchangeable May-2024) Hadlima: Samsung Bioepis / Organon (July-2019; High Concentration August-2022) Abrilada: Pfizer (November-2019; Interchangeable October-2023) Hulio®: Mylan (July-2020) Yusimry: Coherus (December-2021) Idacio®: Fresenius Kabi (December-2022) Yuflyma®: Celltrion (May-2023, High Concentration) Simlandi®: Alvotech / Teva (February-2024, High Concentration Interchangeable)

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

Hadlima: Samsung Bioepis (sBLA for Interchangeability Status: November-2023) Yuflyma®: Celltrion (sBLA for Interchangeability Status: January-2024)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Adalimumab Injection (Pfizer Canada) (January-2021)
Amjevita (Amgen) (November-2020)
Hadlima (Samsung Bioepis) (May-2018, high-concentration January-2023)
Hulio® (Viatris / Fujifilm Kyowa Kirin) (February-2021)
Hyrimoz® (Sandoz Canada) (November-2020)
Idacio® (Fresenius Kabi) (October-2020)
Simlandi (high-concentration) (Alvotech / JAMP) (January-2022)
Yuflyma® (high-concentration) (Celltrion) (December-2021)

Biosimilars Approved In The E.U.

Amgevita / Solymbic (Amgen) (March-2017)
Amsparity (Pfizer) (February-2020)
Cyltezo (Boehringer Ingelheim) (November-2017)
Halimatoz (Sandoz) (July-2018)
Hefiya (Sandoz) (July-2018)
Hulio® (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)
Hyrimoz® (Sandoz) (July-2018 low-concentration, April-2023 high-concentration)
Idacio® (Fresenius Kabi) (April-2019)
Imraldi (Samsung Bioepis) (August-2017)
Kromeya (Fresenius Kabi) (April-2019)
Libmyris / Hukyndra (high and low-concentration) (Stada Arzneimittel AG / Alvotech) (November-2021)
Yuflyma® (Celltrion) (February-2021 low-concentration, February-2022 high-concentration)

Biosimilars Approved In Australia

Abrilada (Pfizer) (February-2021)
Amgevita (Amgen) (November-2017)
Ciptunec / Ardalicip (high-concentration) (Alvotech / Cipla) (November-2022)
Hadlima (Samsung Bioepis) (January-2018)
Hulio (Alphapharm) (February-2021)
Hyrimoz® (Sandoz) (May-2019)
Idacio® (Fresenius Kabi) (June-2020)
Yuflyma (Celltrion) (February-2022)

Biosimilars Approved In Japan

Adalimumab BS (Fujifilm Kyowa Kirin Biologics / Viatris / Sandoz) (June-2020)
Adalimumab BS MA (LG Chem / Mochida Pharmaceutical) (March-2021)

Biosimilars Approved In South Korea

Adalloce (Samsung Bioepis) (September-2017, high-concentration January-2023)
Xelenka (high-concentration) (LG Chem) (December-2023)
Yuflyma® (high-concentration) (Celltrion) (October-2021)

approved_indications 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: Claims 1-8, 10-13, 15-30

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: Claims 1-4, 9-18, 20-30

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

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)

IPR2016-00408

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: Claims 1-5

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

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

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed (with U.S. as Intervenor, Boehringer Ingelheim Withdrew as a Party)

IPR2016-00409

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: Claims 1-5

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

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

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed (with U.S. as Intervenor, Boehringer Ingelheim Withdrew as a Party)

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

IPR2017-01823

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: Claims 1-29

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2017-01824

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: Claims 1-16

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

IPR2017-01987

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: Claims 1-6

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

IPR2017-01988

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: Claims 1-6

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

IPR2017-02105

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: Claims 1, 4, 7, 10, 13, 16, 19

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

IPR2017-02106

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: Claims 1, 5, 6

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1, 2, 5-7

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

IPR2018-00002

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: Claims 1-16

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

IPR2018-00156

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: Claims 1-30

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):

1:11-cv-02541 (S.D.N.Y.)

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

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

1:17-cv-01065 (D. Del.)

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
Stipulated Dismissal

BPCIA
Y

1:21-cv-02258 (N.D. Ill.)

U.S. Patent Nos.
8,420,081 (Antibody Formulations and Methods of Making Same) 8,926,975 (Method of Treating Ankylosing Spondylitis) 8,961,973 (Multiple-Variable Dose Regimen for Treating TNF-Alpha-Related Disorders) 9,085,619 (Anti-TNF Antibody Formulations)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Alvotech hf.

Status
Dismissed due to Settlement

BPCIA
Y

1:21-cv-02899 (N.D. Ill.)

U.S. Patent Nos.
6,805,686 (Autoinjector with Extendable Needle Protector Shroud) 8,231,876 (Purified Antibody Composition) 8,663,945 (Methods of Producing Anti-TNF-Alpha Antibodies in Mammalian Cell Culture) 8,708,968 (Removal of Needle Shields from Syringes and Automatic Injection Devices) 8,715,664 (Use of Human TNF Alpha Antibodies for Treatment of Erosive Polyarthritis) 8,808,700 (Use of TNF Alpha Inhibitor for Treatment of Erosive Polyarthritis) 8,883,156 (Purified Antibody Composition) 8,889,136 (Multiple-Variable Dose Regimen for Treating TNF Alpha-Related Disorders) 8,895,009 (Purified Antibody Composition) 8,906,372 (Purified Antibody Composition) 8,906,373 (Use of TNF-Alpha Inhibitor for Treatment of Psoriasis) 8,906,646 (Fed-Batch Method of Making Human Anti-TNF-Alpha Antibody) 8,911,737 (Methods of Administering Anti-TNF Alpha Antibodies) 8,911,964 (Fed-Batch Method of Making Human Anti-TNF-Alpha Antibody) 8,916,153 (Purified Antibody Composition) 8,961,974 (Multiple-Variable Dose Regimen for Treating TNF Alpha-Related Disorders) 8,974,790 (Methods of Administering Anti-TNF Alpha Antibodies) 8,986,693 (Use of TNF Alpha inhibitor for Treatment of Psoriasis) 8,992,926 (Methods of Administering Anti-TNF Alpha Antibodies) 8,999,337 (Methods for Treating Juvenile Idiopathic Arthritis by Inhibition of TNF Alpha) 9,061,005 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease) 9,062,106 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,067,992 (Use of TNF Alpha Inhibitor for Treatment of Psoriatic Arthritis) 9,085,618 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,085,620 (Use of TNF Alpha Inhibitor for Treatment of Psoriatic Arthritis) 9,090,688 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,090,689 (Use of TNF Alpha Inhibitor for Treatment of Psoriasis) 9,090,867 (Fed-Batch Method of Making Anti-TNF-Alpha Antibody) 9,096,666 (Purified Antibody Composition) 9,102,723 (Purified Antibody Composition) 9,150,645 (Cell Culture Methods to Reduce Acidic Species) 9,181,337 (Modulated Lysine Variant Species Compositions and Methods for Producing and Using the Same) 9,181,572 (Methods to Modulate Lysine Variant Distribution) 9,187,559 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease) 9,234,032 (Fed-Batch Methods for Producing Adalimumab) 9,266,949 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,273,132 (Purified Antibody Composition) 9,284,370 (Methods for Treating Juvenile Idiopathic Arthritis) 9,284,371 (Methods for Producing Adalimumab) 9,290,568 (Methods to Control Protein Heterogeneity) 9,315,574 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,328,165 (Purified Antibody Composition) 9,334,319 (Low Acidic Species Compositions) 9,339,610 (Removal of Needle Shield from Syringes and Automatic Injection Devices) 9,346,879 (Protein Purification Methods to Reduce Acidic Species) 9,359,434 (Cell Culture Methods to Reduce Acidic Species) 9,499,614 (Methods for Modulating Protein Glycosylation Profiles of Recombinant Protein Therapeutics Using Monosaccharides and Oligosaccharides) 9,499,616 (Modulated Lysine Variant Species Compositions and Methods for Producing and Using the Same) 9,505,834 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,512,216 (Use of TNF Alpha Inhibitor) 9,522,953 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,546,212 (Methods of Administering Anti-TNF Alpha Antibodies) 9,550,826 (Glycoengineered Binding Protein Compositions) 9,624,295 (Uses and Compositions for Treatment of Psoriatic Arthritis) 9,669,093 (Methods for Treating Juvenile Idiopathic Arthritis) 9,683,033 (Cell Culture Methods to Reduce Acidic Species) 9,708,400 (Methods to Modulate Lysine Variant Distribution) 9,957,318 (Protein Purification Methods to Reduce Acidic Species) 11,083,792 (Purified Antibody Composition) 11,167,030 (Protein Formulations and Methods of Making Same) 11,191,834 (Protein Formulations and Methods of Making Same)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Alvotech hf.

Status
Dismissed due to Settlement

BPCIA
Y

1:21-cv-05645 (N.D. Ill.) (transferred from 2:21-cv-00265 (E.D. Va.))

U.S. Patent Nos.
8,420,081 (Antibody Formulations and Methods of Making Same) 8,926,975 (Method of Treating Ankylosing Spondylitis) 8,961,973 (Multiple-Variable Dose Regimen for Treating TNF-Alpha-Related Disorders) 9,085,619 (Anti-TNF Antibody Formulations)

Plaintiffs
Alvotech USA Inc.; Alvotech hf.

Defendants
AbbVie Biotechnology Ltd.; AbbVie Inc.

Status
Voluntarily Dismissed

BPCIA
N

2:07-cv-00139 (E.D. Tex.)

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

2:09-cv-00389 (E.D. Tex.)

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

2:16-cv-00322 (E.D. Va.)

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

3:18-cv-12668 (D.N.J.)

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 due to Settlement

BPCIA
Y

4:09-cv-40002 (D. Mass.)

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

4:09-cv-40061 (D. Mass.)

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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Venable’s BiologicsHQ Monthly Injection – June 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
July 9, 2024
FDA Revises Guidance on Switching Studies for Biosimilar Interchangeability
Robert S. Schwartz, Ph.D.
June 27, 2024
Venable’s BiologicsHQ Monthly Injection – May 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
June 11, 2024
Venable’s BiologicsHQ Monthly Injection – April 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
May 16, 2024
FDA Approves High-Concentration Formulation of Boehringer Ingelheim’s Humira® Biosimilar Cyltezo® (adalimumab-adbm)
Monica Chou Robert S. Schwartz, Ph.D.
May 8, 2024
Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), Biosimilar to Stelara® Approved by FDA
Monica Chou Robert S. Schwartz, Ph.D.
April 23, 2024
Venable’s BiologicsHQ Monthly Injection – March 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
April 10, 2024
Ha Kung Wong Discusses Antitrust Lawsuits on Increasing Biosimilar Accessibility with The Center for Biosimilars
Ha Kung Wong
March 29, 2024
Ha Kung Wong Discusses Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars with The Center for Biosimilars
Ha Kung Wong
March 29, 2024
Biden FY25 HHS Budget Eliminates the Separate Interchangeability Designation for Biosimilars
Robert S. Schwartz, Ph.D.
March 15, 2024
Venable’s BiologicsHQ Monthly Injection – February 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
March 13, 2024
First High-Concentration Humira® Interchangeable, Alvotech and Teva’s Simlandi®, Approved in the U.S.
Robert S. Schwartz, Ph.D.
February 29, 2024
Venable’s BiologicsHQ Monthly Injection – January 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
February 13, 2024
Venable’s BiologicsHQ Monthly Injection – December 2023
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
January 13, 2024
Venable’s BiologicsHQ Monthly Injection – September 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 16, 2023
Venable’s BiologicsHQ Monthly Injection – August 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 12, 2023
Venable’s BiologicsHQ Monthly Injection – July 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 15, 2023
What Do the Humira Biosimilar / Interchangeable Launches Mean for the Adalimumab Market?
April Breyer Menon Ha Kung Wong
August 7, 2023
Venable’s BiologicsHQ Monthly Injection – June 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 15, 2023
Venable’s BiologicsHQ Monthly Injection – May 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 13, 2023
Venable’s BiologicsHQ Monthly Injection – April 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 8, 2023
Venable’s BiologicsHQ Monthly Injection – March 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 10, 2023
The State of Biosimilars in 2023
April Breyer Menon Ha Kung Wong
March 17, 2023
Venable’s BiologicsHQ Monthly Injection – February 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 15, 2023
Venable’s BiologicsHQ Monthly Injection – January 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
February 9, 2023
First Humira Biosimilar Enters the U.S. Market
April Breyer Menon Ha Kung Wong
February 3, 2023
Venable’s BiologicsHQ Monthly Injection – December 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
January 12, 2023
Venable’s BiologicsHQ Monthly Injection – November 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
December 14, 2022
Venable’s BiologicsHQ Monthly Injection – October 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
November 14, 2022
Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 11, 2022
Venable’s BiologicsHQ Monthly Injection – August 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 8, 2022
First Interchangeable FDA Approval without a Switching Study
April Breyer Menon Ha Kung Wong
August 31, 2022
Venable’s BiologicsHQ Monthly Injection – July 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 5, 2022
Venable’s BiologicsHQ Monthly Injection – June 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 8, 2022
Venable’s BiologicsHQ Monthly Injection – May 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 7, 2022
Venable’s BiologicsHQ Monthly Injection – April 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 9, 2022
Venable’s BiologicsHQ Monthly Injection – March 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 18, 2022
Venable’s BiologicsHQ Monthly Injection – February 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 8, 2022
Viatris and Biocon Launch First Interchangeable Insulin in the U.S.
April Breyer Menon
November 30, 2021
Venable’s BiologicsHQ Monthly Injection – October 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
November 10, 2021
FDA Approves Boehringer Ingelheim’s Cyltezo® as Interchangeable with Humira®
April Breyer Menon
October 25, 2021
Venable’s BiologicsHQ Monthly Injection – September 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 12, 2021
Venable’s BiologicsHQ Monthly Injection – August 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
September 8, 2021
Venable’s BiologicsHQ Monthly Injection – July 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 11, 2021
Venable’s BiologicsHQ Monthly Injection – June 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 13, 2021
Venable’s BiologicsHQ Monthly Injection – May 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 17, 2021
Venable’s BiologicsHQ Monthly Injection – April 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 12, 2021
Boehringer Ingelheim Applies for Interchangeability Designation for Cyltezo® (adalimumab-adbm)
April Breyer Menon
April 26, 2021
Venable’s BiologicsHQ Monthly Injection – March 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 7, 2021
Venable’s BiologicsHQ Monthly Injection – February 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 9, 2021
Venable’s BiologicsHQ Monthly Injection – January 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
February 8, 2021
Venable’s BiologicsHQ Monthly Injection – December 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
January 12, 2021
Venable’s BiologicsHQ Monthly Injection – November 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
December 9, 2020
Venable’s BiologicsHQ Monthly Injection – October 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
November 9, 2020
Venable’s BiologicsHQ Monthly Injection – September 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 8, 2020
Venable’s BiologicsHQ Monthly Injection – August 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 9, 2020
Venable’s BiologicsHQ Monthly Injection – July 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 10, 2020
Venable’s BiologicsHQ Monthly Injection – June 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 9, 2020
Venable’s BiologicsHQ Monthly Injection – May 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 8, 2020
Venable’s BiologicsHQ Monthly Injection – April 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
May 6, 2020
Venable’s BiologicsHQ Monthly Injection – March 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
April 8, 2020
Venable’s BiologicsHQ Monthly Injection – February 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
March 12, 2020
Venable’s BiologicsHQ Monthly Injection – January 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
February 6, 2020
Venable’s BiologicsHQ Monthly Injection – December 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
January 7, 2020
Venable’s BiologicsHQ Monthly Injection – November 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
December 9, 2019
Venable’s BiologicsHQ Monthly Injection – October 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
November 11, 2019
Venable’s BiologicsHQ Monthly Injection – September 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
October 8, 2019
Venable’s BiologicsHQ Monthly Injection – August 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
September 9, 2019
Venable’s BiologicsHQ Monthly Injection – July 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
August 6, 2019
Venable’s BiologicsHQ Monthly Injection – June 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
July 9, 2019
Venable’s BiologicsHQ Monthly Injection – May 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
June 6, 2019
Venable’s BiologicsHQ Monthly Injection – April 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
May 7, 2019
Venable’s BiologicsHQ Monthly Injection – March 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
April 5, 2019
Venable’s BiologicsHQ Monthly Injection – February 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2019
Venable’s BiologicsHQ Monthly Injection – January 2019
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
February 11, 2019
Venable’s BiologicsHQ Monthly Injection – December 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 9, 2019
Venable’s BiologicsHQ Monthly Injection – November 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
December 11, 2018
Venable’s BiologicsHQ Monthly Injection – October 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
November 12, 2018
VIDEO: Noteworthy Ongoing Biosimilar Litigation
Ha Kung Wong
November 6, 2018
Venable’s BiologicsHQ Monthly Injection – September 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
October 6, 2018
Venable’s BiologicsHQ Monthly Injection – August 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
September 6, 2018
Venable’s BiologicsHQ Monthly Injection – July 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
August 3, 2018
Venable’s BiologicsHQ Monthly Injection – June 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
July 6, 2018
Venable’s BiologicsHQ Monthly Injection – May 2018
April M. Breyer Menon Joseph K. Yarsky Corinne E. Atton Robert S. Schwartz, Ph.D.
June 8, 2018
Venable’s BiologicsHQ Monthly Injection – April 2018
April M. Breyer Menon Corinne E. Atton Joseph K. Yarsky Robert S. Schwartz, Ph.D.
May 3, 2018
Venable’s BiologicsHQ Monthly Injection – March 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
April 6, 2018
Venable’s BiologicsHQ Monthly Injection – February 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2018
Venable’s BiologicsHQ Monthly Injection – December 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 8, 2018
Venable’s BiologicsHQ Monthly Injection – November 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
December 5, 2017
Venable’s BiologicsHQ Monthly Injection – October 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
November 3, 2017
Venable’s BiologicsHQ Monthly Injection – August/September 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
October 5, 2017
VIDEO: Will Biosimilar Applicants Still Participate in the Patent Dance?
Ha Kung Wong
August 11, 2017
VIDEO: How Important is Inter Partes Review to Biosimilars?
Ha Kung Wong
August 9, 2017
Venable’s BiologicsHQ Monthly Injection – July 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
July 26, 2017

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.

Disclaimer

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