Tofidence — Venable's BiologicsHQ

U.S. License Holder:

Biogen / Bio-Thera

Date of License:

September-29-2023

Last Update:

Dec-15-2024

FDA-Approved Indications

TOFIDENCE (tocilizumab-bavi) 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;

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;

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).

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Tofidence (Biogen / Bio-Thera) (June-2024)

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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Tofidence (tocilizumab-bavi)

Tofidence (tocilizumab-bavi)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

U.S. Patent Litigations

Case No(s):

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

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