Biocon Biologics gets US FDA nod for Jobevne, a biosimilar for cancer treatment

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd has received U.S. Food and Drug Administration (U.S. FDA) approval for its Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use.

“JOBEVNE™ (bevacizumab-nwgd) is 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,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., in a statement.

JOBEVNE is a recombinant humanised monoclonal antibody, used to treat several types of cancer. A recombinant humanized monoclonal antibody is a lab-made protein that closely mimics natural antibodies in the human body and is designed to target specific disease cells, like cancer. The antibody works by targeting and blocking vascular endothelial growth factor (VEGF). By inhibiting VEGF, it helps prevent the formation of new blood vessels (angiogenesis), cutting off the tumour’s blood supply and slowing its growth.

The company explained in an exchange filing that JOBEVNE is designed to closely match the reference product, Avastin®. The approval was supported by a robust package of data, including comparative pharmacokinetics, safety, efficacy, structural and analytical studies, as well as functional and nonclinical evidence.

These studies confirmed that JOBEVNE is highly similar to Avastin®, with no clinically meaningful differences in how the drug works in the body, its safety profile, effectiveness, or potential to trigger immune responses, the company said in its filing on Thursday.

In 2023, bevacizumab sales in the U.S. were around $2.0 billion. Biocon Biologics currently serves over 5 million patients each year across its global operations. This is a significant addition to the company’s growing cancer treatment portfolio in the U.S., which already includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The company also sells Bevacizumab under the brand name ABEVMY in Europe (approved in February 2021) and Canada (approved in November 2021). Overall, Biocon Biologics now has seven approved biosimilars in the U.S. and six in Canada. Its pipeline includes 20 biosimilars in various stages of development, covering treatments like insulins and monoclonal antibodies across different therapy areas.