FKB238 (bevacizumab)

FKB238 Approval Pending

FKB238 (bevacizumab)

FKB238 Approval Pending

U.S. License Holder:

Centus / Fujifilm Kyowa Kirin

Date of License:

aBLA accepted by FDA November-2019

Last Update:

Feb-15-2025

approved_indications FDA-Approved Indications

FKB238 (bevacizumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:20-cv-00361 (E.D. Tex.)

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) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 9,441,035 (Cell Culture Media and Methods of Antibody Production) 9,795,672 (Treatment with Anti-VEGF Antibodies) 10,017,732 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,208,355 (Method of Treatment for Glioblastoma by Administering a VEGF Antagonist) 10,336,983 (Method for Increasing the Specific Production Rate of Eukaryotic Cells) 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
Centus Biotherapeutics Limited; Fujifilm Corporation; Fujifilm Kyowa Kirin Biologics Co., Ltd.; Kyowa Kirin 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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