Avtozma® (tocilizumab-anoh)

aBLA No. Not Yet Available

Avtozma® (tocilizumab-anoh)

aBLA No. Not Yet Available

U.S. License Holder:

Celltrion

Date of License:

January-30-2025

Last Update:

Jan-31-2025

approved_indications FDA-Approved Indications

AVTOZMA (tocilizumab-anoh) 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_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In South Korea

Avtozma® (Celltrion) (December-2024)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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

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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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