FDA Approves Biocon Biologics' Bevacizumab Biosimilar

The present approval adds to the company’s growing oncology portfolio in the US, which already includes Ogivri (trastuzumab-dkst) for HER2-positive breast cancer and Fulphila (pegfilgrastim-jmdb) to reduce the risk of febrile neutropenia in patients undergoing chemotherapy. | Image Credit: gguy - stock.adobe.com .jpeg

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).^1,2

The new recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF) receptors is indicated for the treatment of colorectal cancer, non–small cell lung cancer, glioblastoma, renal cell carcinoma, and cervical cancer, ovarian, fallopian tube, and primary peritoneal cancers.¹

"The U.S\ FDA approval of Jobevne (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," commented Shreehas Tambe, CEO and managing director, Biocon Biologics, in a statement.

In addition to cancer indications, reference bevacizumab (Avastin) is often used off label for age-related macular degeneration, diabetic macular edema, retinal vein occlusions, neovascular glaucoma, corneal vascularization, pterygium, and after trabeculectomy to prevent bleb failure.³ Biosimilars could provide greater access to biosimilar therapies for these conditions as well.

Jobevne joins 5 other Avastin competitors: Celltrion's Vegzelma (bevacizumab-adcd), Amgen/Allergan's Mvasi (bevacizumab-awwb), Pfizer's Zirabev (bevacizumab-bvzr), Amneal Pharmaceuticals/Kashiv Biosciences Alymsys (bevacizumab-maly), and Sandoz/Bio-Thera Solutions' Avzivi (bevacizumab-tnjn).²

The present approval adds to the company’s growing oncology portfolio in the US, which already includes Ogivri (trastuzumab-dkst) for HER2-positive breast cancer and Fulphila (pegfilgrastim-jmdb) to reduce the risk of febrile neutropenia in patients undergoing chemotherapy.¹ The biosimilar has also been approved in Europe and Canada, where it's marketed under the brand name Abevmy.²

In addition to its oncology biosimilars, the company has made significant strides in diabetes care with the launch of Semglee (insulin glargine-yfgn), the first interchangeable biosimilar approved in the US.⁴ With products in over 120 countries and a pipeline packed with 20 biosimilars in development across different therapeutic areas, the company said it is keeping its focus on making high-quality biologics more accessible and affordable for people around the world.

References

1. Biocon Biologics announces U.S. FDA approval for Jobevne, biosimilar bevacizumab, expanding Its oncology portfolio. Press release. Biocon Biologics; April 10, 2025. Accessed April 10, 2025. https://www.biocon.com/biocon-biologics-announces-u-s-fda-approval-for-jobevne-biosimilar-bevacizumab-expanding-its-oncology-portfolio/

2. Biosimilar approvals. The Center for Biosimilars^®. Updated April 10, 2025. Accessed April 10, 2025. https://www.centerforbiosimilars.com/biosimilar-approvals

3. Singh S, Saxena S, Akduman L, Meyer CH. Off-label use of intravitreal bevacizumab: a global conundrum. Indian J Ophthalmol. 2024;72(5):617-619. doi:10.4103/IJO.IJO_2166_23

4. Hagen T. FDA approves Semglee insulin glargine as first interchangeable biosimilar. The Center for Biosimilars. July 28, 2021. Accessed April 10, 2025. https://www.centerforbiosimilars.com/view/fda-approves-semglee-insulin-glargine-as-first-interchangeable-biosimilar