Celltrion Earns FDA Nod for Bevacizumab Biosimilar

On September 28, the Food and Drug Administration (FDA) approved Celltrion’s Vegzelma™, a biosimilar to Roche’s Avastin®. Dubbed bevacizumab-adcd, this vascular endothelial growth factor (VEGF) is indicated for the treatment of:

  • Recurrent or advanced nonsquamous non–small cell lung cancer
  • Metastatic renal cell carcinoma
  • Recurrent glioblastoma
  • Recurrent or advanced cervical cancer
  • Epithelial ovarian cancer
  • Fallopian tube tumors
  • Peritoneal cancer

The approval of Celltrion’s Vegzelma marks the company’s fourth biosimilar approval. It will rely on its Celltrion USA subsidiary to market the biosimilar in this country when it is launched in 2023. This will be the first time that Celltrion will utilize its own salesforce to attain marketshare in the US. Marketing partners for their other biosimilar products are Pfizer and Teva.

Vegzelma is the fourth bevacizumab biosimilar to receive FDA approval. Within three years of launch, the two marketed bevacizumab biosimilars (Mvasi® and Zirabev®) dominated the reference product in terms of marketshare. The competitive field may become more crowded within the next 18 months, with the launches of Amneal’s Alymsys® and Vegzelma in 2023, and FDA decisions expected within the next 18 months for Viatris’ MYL-1402O, Samsung Bioepis’ SB-8, and Sandoz’s BAT-1706.  

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