SB8 (bevacizumab)

SB8 Approval Pending

SB8 (bevacizumab)

SB8 Approval Pending

U.S. License Holder:

Samsung Bioepis

Date of License:

aBLA accepted by FDA November-2019

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

SB8 (bevacizumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Aybintio (Samsung Bioepis) (November-2021)

Biosimilars Approved In The E.U.

Aybintio (Samsung Bioepis) (August-2020)
Onbevzi® (Samsung Bioepis) (January-2021)

Biosimilars Approved In Australia

Onbevzi® (Samsung Bioepis) (January-2024)

Biosimilars Approved In South Korea

Onbevzi® (Boryung Pharmaceutical / Samsung Bioepis) (September-2021)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:20-cv-00859 (D. Del.)

U.S. Patent Nos.
6,586,206 (Methods for Making Recombinant Proteins Using Apoptosis Inhibitors) 7,390,660 (Methods for Growing Mammalian Cells In Vitro) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO.sub.2 in the Medium) 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) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,487,809 (Decreasing Lactate Level and Increasing Polypeptide Production by Downregulating the Expression of Lactate Dehydrogenase and Pyruvate Dehydrogenase Kinase) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 9,795,672 (Treatment with Anti-VEGF Antibodies) 10,208,355 (Method of Treatment for Glioblastoma by Administering a VEGF Antagonist) 10,513,697 (CO.sub.2 Profile Cultivation) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,676,710 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production)

Plaintiffs
Genentech, Inc.

Defendants
Samsung Bioepis Co., Ltd.

Status
Settled

BPCIA
Y

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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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