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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.

References        

  1. FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate. Samsung Bioepis. Published November 19, 2019. https://bwnews.pr/2raHsEk. 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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