FDA Greenlights Bevacizumab Biosimilar Across Cancer Types
The FDA has approved bevacizumab-nwgd, a biosimilar to bevacizumab, for intravenous use across multiple cancer types.
US FDA
- A new bevacizumab (Avastin) biosimilar, bevacizumab-nwgd (Jobevne), has been approved for the treatment of various cancers.
- Bevacizumab-nwgd offers a potentially more affordable treatment option.
- The biosimilar demonstrated comparable efficacy and safety to reference product.
The FDA has granted approval to bevacizumab-nwgd (Jobevne), a biosimilar of bevacizumab, for intravenous administration.1
This recombinant humanized monoclonal antibody acts as a vascular endothelial growth factor (VEGF) inhibitor, binding to VEGF and blocking its interaction with receptors. This mechanism inhibits angiogenesis, thereby restricting blood supply to tumors and combating cancer growth.1
This approval was supported by data from a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional results that showed the biosimilar to be highly similar to bevacizumab. There were no clinically meaningful differences between bevacizumab and the bevacizumab biosimilar in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
"The US FDA approval of [bevacizumab-nwgd] is a significant milestone—our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients,” stated Shreehas Tambe, chief executive officer and managing director of Biocon Biologics Ltd., in a press release.
Bevacizumab-nwgd is indicated for the treatment of several cancers, including:
- Metastatic colorectal cancer (first- or second-line, and second-line post-bevacizumab progression).
- Unresectable, locally advanced, recurrent or metastatic nonsquamous non–small cell lung cancer (first-line).
- Recurrent glioblastoma in adult patients.
- Metastatic renal cell carcinoma (in combination with interferon alfa).
- Persistent, recurrent, or metastatic advanced cervical cancer (in combination with specific chemotherapies).
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer (in various combinations and settings, including first-line and recurrent disease).
