FDA Approves Bevacizumab Biosimilar for Various Cancer Types

The FDA has approved bevacizumab-nwgd (Jobevne; Biocon Biologics), a biosimilar referencing bevacizumab (Avastin; Genentech) for the treatment of several different types of cancers. This approval marks bevacizumab-nwgd as the sixth reference product to bevacizumab.¹

Image credit: Olivier Le Moal | stock.adobe.com

As a recombinant humanized monoclonal antibody, bevacizumab-nwgd binds with vascular endothelial growth factor (VEGF) inhibitor and blocks the interaction with its receptors. This prevents angiogenesis and restricts the blood supply to cancerous tumors.¹

The biosimilar is indicated to treat colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. However, the company emphasized that bevacizumab-nwgd should not be used for adjuvant treatment of colon cancer.¹

"The US FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. 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,” said Shreehas Tambe, CEO & managing director, Biocon Biologics, in a news release.¹

The approval of bevacizumab-nwgd was granted based on a comprehensive data package that demonstrated its similarity to the reference drug. The package confirmed comparable safety, efficacy, nonclinical, structural, analytical, and functional data. Additionally, no clinically meaningful differences were found between the biosimilar and the reference product in terms of pharmacokinetics, safety, efficacy, and immunogenicity.¹

As the sixth approved biosimilar for Avastin, Jobevne joins Mvasi (bevacizumab-awwb; Amgen, Allergan), Zirabev (bevacizumab-bvzr; Pfizer), Alymsys (bevacizumab-maly; Amneal Pharmaceuticals), Vegzelma (bevacizumab-adcd; Celltrion USA), and Avzivi (bevacizumab-tnjn; Bio-Thera Solutions).³

The most common adverse events found across studies for the reference product, bevacizumab, include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.²

Biocon Biologics’ oncology biosimilar portfolio has expanded in the US with the approval of bevacizumab-nwgd, joining trastuzumab-dkst (Ogivri) for the treatment of HER2-positive breast cancer and pegfilgrastim-jmdb (Fulphila), which is indicated to reduce the risk of febrile neutropenia in individuals being treated with chemotherapy.¹

REFERENCES

1. Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio. Biocon Biologics. News release. April 10, 2025. Accessed April 11, 2025. https://www.bioconbiologics.com/biocon-biologics-announces-u-s-fda-approval-for-jobevne-biosimilar-bevacizumab-expanding-its-oncology-portfolio/

2. Avastin. Import Safety Information & Indication. Accessed April 11, 2025. https://www.avastin.com/hcp.html

3. The 4 Biosimilars for Avastin, and What You Should Know About Them. GoodRx. News release. Published January 23, 2023. Accessed April 11, 2025. https://www.goodrx.com/avastin/biosimilar-drug