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FDA Accepts Application for Bevacizumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Tuesday, Nov 19, 2019

The FDA has accepted a biologics license application (BLA) for the proposed bevacizumab (Avastin) biosimilar SB8, according to Samsung Bioepis, the developer of the agent.1

In June 2019, the FDA approved the bevacizumab biosimilar PF-06439535 (bevacizumab-bvzr; Zirabev), for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous NSCLC; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.


  1. FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate. Samsung Bioepis. Published November 19, 2019. Accessed November 19, 2019.       
  2. Reck M, et al. A phase III study comparing SB8, a proposed bevacizumab biosimilar, and reference bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. Presented at: European Society for Medical Oncology Congress 2019; September 27 to October 1, 2019; Barcelona, Spain. Abstract 1565P.

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