Biocon Biologics, a subsidiary of Indian drugmaker Biocon, has secured the US Food and Drug Administration (FDA) approval for Jobevne, a biosimilar to Roche’s Avastin (bevacizumab), expanding its oncology portfolio.
Jobevne, a recombinant humanised monoclonal antibody, is intended to treat various cancers by inhibiting the vascular endothelial growth factor (VEGF).
The FDA approval of Jobevne is based on extensive data that demonstrated its high similarity to the reference product, Avastin.
The data included comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical, and functional assessments, confirming no clinically meaningful differences between Jobevne and Avastin.
Biocon Biologics CEO and managing director Shreehas Tambe said: “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.
“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.”
Biocon Biologics, a global biosimilars company, develops a portfolio of approved and in-development biosimilars across multiple therapies.
It leverages advanced science, technology platforms, manufacturing capabilities, and quality systems to reduce the cost of biological therapeutics while enhancing healthcare outcomes.
With the approval, Biocon Biologics enhances its biosimilar oncology portfolio in the US, which already includes Ogivri (Trastuzumab-dkst) and Fulphila (Pegfilgrastim-jmdb).
The company also markets Bevacizumab in Canada and Europe under the name Abevmy, with approvals received in November 2021 and February 2021, respectively.
Biocon Biologics has seven approved biosimilars in the US and six in Canada, alongside a development pipeline of 20 biosimilar assets.
