Bevacizumab Biosimilar Granted FDA Approval for Several Cancer Types

The biosimilar is indicated for several lines of therapy across cancer types.

The FDA granted approval to bevacizumab-nwgd (Jobevne), a biosimilar for bevacizumab (Avastin), for indications in several cancer types including colorectal cancer; non-squamous non-small cell lung cancer; glioblastoma; renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to a news release from Biocon Biologics Ltd, the developer of the biosimilar.

“The U.S. 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,” CEO and Managing Director of Biocon Biologics Ltd Shreehas Tambe in the announcement. “It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics.”

Cancer Types and Treatment Lines Indicated

The approval is indicated for cancers including metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment and 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.

Bevacizumab-nwgd is also indicated for unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel chemotherapy as a first-line treatment as well as in recurrent glioblastoma in adults; metastatic renal cell carcinoma, in combination with interferon alfa and persistent, recurrent, or metastatic advanced cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.

Additionally, it is indicated for epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by bevacizumab-nwgd as a single agent for stage 3 or 4 disease following initial surgical resection; with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens and in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab-nwgd as a single agent, for platinum-sensitive recurrent disease.

The news release further notes that bevacizumab-nwgd is not indicated for the adjuvant, or postsurgical, treatment of colon cancer.

About Bevacizumab-nwgd

Bevacizumab-nwgd, according to the news release, is a recombinant humanized monoclonal antibody, VEGF inhibitor.

The approval of bevacizumab-nwgd, according to the news release, was based on pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data confirming that bevacizumab-nwgd is highly similar to bevacizumab, with no clinically meaningful differences in pharmacokinetics, safety, efficacy and immunogenicity.

Biocon Biologics Ltd., as it noted in the news release, also markets bevacizumab in Europe and Canada under the name Abevmy, with those approvals having been issued in February 2021 and November 2021, respectively.

Reference

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