Actemra® — Venable's BiologicsHQ

U.S. License Holder:

Genentech

Date of License:

January-08-2010 [October-21-2013]

Last Update:

Nov-15-2024

FDA-Approved Indications

ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

Rheumatoid Arthritis (RA): Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs);

Giant Cell Arteritis (GCA): Adult patients with giant cell arteritis;

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD);

Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis;

Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active systemic juvenile idiopathic arthritis;

Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome;

Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

aBLA / 505(b)(2) Activity

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

Tofidence: Biogen / Bio-Thera (September-2023) Tyenne®: Fresenius Kabi (March-2024)

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

CT-P47: Celltrion (January-2024)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Tofidence: Biogen / Bio-Thera (June-2024)
Tyenne® (Fresenius Kabi) (September-2023)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2021-01024

U.S. Patent No.
7,521,052 (Methods for Treating Interleukin-6 Related Diseases)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y: Claim 1

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claim 1

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution

IPR2021-01025

U.S. Patent No.
10,744,201 (Method for Treating Rheumatoid Arthritis with a Human IL-6 Receptor Antibody and Methotrexate)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y: Claims 1-15

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-15

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution

IPR2021-01288

U.S. Patent No.
8,580,264 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Genentech, Inc.; Hoffmann-La Roche Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y: Claims 1-3, 6-11

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-3, 6-11

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution

IPR2021-01336

U.S. Patent No.
10,874,677 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y: Claims 1, 5

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-8

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution

IPR2021-01542

U.S. Patent No.
8,580,264 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Genentech, Inc.; Hoffmann-La Roche Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, Inc.; Fresenius SE & Co. KGaA

§ 102 Challenge
Y: Claim 12

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 4, 5, 12

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution

IPR2022-00201

U.S. Patent No.
9,750,752 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, LLC; Fresenius SE & Co. KGaA

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-16

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

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

IPR Status
Settled After Institution

IPR2022-00578

U.S. Patent No.
8,580,264 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.; Genentech, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co. Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y: Claims 1-3, 6-12

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-12

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
24-1115 (Consolidated with lead appeal 24-1111)

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Voluntarily Dismissed

IPR2022-00579

U.S. Patent No.
10,874,677 (Subcutaneously Administered Anti-IL6 Receptor Antibody)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.; Genentech, Inc.

Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co. Ltd.; Celltrion Healthcare USA, Inc.

§ 102 Challenge
Y: Claims 1, 5

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-8

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
24-1111 (Lead, consolidated with 24-1115)

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Voluntarily Dismissed

IPR2022-01065

U.S. Patent No.
10,231,981 (Subcutaneously Administered Anti-IL6 Receptor Antibody for Treatment of Juvenile Idiopathic Arthritis)

Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.

Petitioner(s)
Fresenius Kabi USA, LLC; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi AG; Fresenius Kabi Deutschland GmbH; Fresenius Kabi Pharmaceuticals Holding, LLC; Fresenius SE & Co. KGaA

§ 102 Challenge
Y: Claims 1-14

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-14

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-11573 (D. Mass.)

U.S. Patent Nos.
7,332,289 (Method of Purifying Protein) 7,521,052 (Methods for Treating Interleukin-6 Related Diseases) 8,398,980 (Subtypes of Humanized Antibody Against Interleuken-6 Receptor) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,734,800 (Subtypes of Humanized Antibody Against Interleukin-6 Receptor) 9,714,293 (Production of Proteins in Glutamine-Free Cell Culture Media) 9,902,777 (Methods for Producing Subtypes of Humanized Antibody Against Interleukin-6 Receptor) 10,017,732 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,336,983 (Method for Increasing the Specific Production Rate of Eukaryotic Cells) 10,501,769 (Method for the Production of a Glycosylated Immunoglobulin) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,676,710 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,744,201 (Method for Treating Rheumatoid Arthritis with a Human IL-6 Receptor Antibody and Methotrexate) 10,829,732 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,982,003 (Production of Proteins in Glutamine-Free Cell Culture Media) 11,021,728 (Method for the Production of a Glycosylated Immunoglobulin) 11,078,294 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 11,136,610 (Method for the Production of a Glycosylated Immunoglobulin) 11,377,678 (Method for the Production of a Glycosylated Immunoglobulin)

Plaintiffs
Genentech, Inc.; Chugai Pharmaceutical Co., Ltd.; Hoffmann-La Roche Inc.

Defendants
Biogen MA Inc.; Bio-Thera Solutions, Ltd.

Status
Stipulated Dismissal Due to Settlement

BPCIA
Y

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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Actemra® (tocilizumab)

Actemra® (tocilizumab)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

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

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

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Inter Partes Review Proceedings

IPR Case No(s):

IPR2021-01024

IPR2021-01025

IPR2021-01288

IPR2021-01336

IPR2021-01542

IPR2022-00201

IPR2022-00578

IPR2022-00579

IPR2022-01065

U.S. Patent Litigations

Case No(s):

1:23-cv-11573 (D. Mass.)

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