U.S. License Holder:
Date of License:
aBLA accepted by FDA November-2019
SB8 (bevacizumab) is not FDA-approved. An aBLA has been accepted by the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Aybintio (Samsung Bioepis) (August-2020) Onbevzi® (Samsung Bioepis) (January-2021)
Biosimilars Approved In South Korea
Onbevzi® (Boryung Pharmaceutical / Samsung Bioepis) (September-2021)
U.S. Patent LitigationsPACER
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)
Samsung Bioepis Co., Ltd.
Case Ongoing, Stayed