The U.S. Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne), a biosimilar to bevacizumab (Avastin), for intravenous use. Bevacizumab-nwgd is a recombinant humanized monoclonal antibody and a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis—combating cancer by restricting blood supply to the tumor.
The approval for bevacizumab-nwgd was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical, and functional data, which confirmed it is highly similar to its reference product bevacizumab. The data demonstrated that there were no clinically meaningful differences between bevacizumab-nwgd and bevacizumab in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
Indications and Usage
Bevacizumab-nwgd is indicated for the treatment of:
- Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment; it is not indicated for the adjuvant treatment of colon cancer.
- Metastatic colorectal cancer, in combination with fluoropyrimidine/irinotecan– or fluoropyrimidine/oxaliplatin–based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen; it is not indicated for the adjuvant treatment of colon cancer.
- Unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
- Recurrent glioblastoma in adults.
- Metastatic renal cell carcinoma in combination with interferon alfa.
- Persistent, recurrent, or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
- In combination with carboplatin and paclitaxel, followed by bevacizumab-nwgd as a single agent, for stage III or IV disease following initial surgical resection
- In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for patients with platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens
- In combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab-nwgd as a single agent, for platinum-sensitive recurrent disease.
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