FDA Approves Biocon’s Jobevne, Bevacizumab Biosimilar

FDA Approves Biocon’s Jobevne, Bevacizumab Biosimilar

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has received approval from the U.S. Food and Drug Administration (FDA) for its cancer treatment biosimilar, Jobevne (bevacizumab-nwgd). The approval marks the company’s seventh biosimilar greenlight in the U.S., strengthening its oncology portfolio and expanding patient access to affordable biologics.

Jobevne is a biosimilar to Avastin (bevacizumab), a widely used intravenous therapy for several types of cancer. As a vascular endothelial growth factor (VEGF) inhibitor, it works by blocking the growth of blood vessels that supply nutrients to tumors, effectively slowing cancer progression.

“This is a significant milestone for Biocon Biologics,” said Shreehas Tambe, CEO and Managing Director of Biocon Biologics Ltd. “The approval underscores our scientific capabilities and commitment to delivering high-quality, affordable treatment options.”

The approval adds to Biocon’s existing oncology offerings in the U.S., which include Ogivri (trastuzumab-dkst) and Fulphila (pegfilgrastim-jmdb). Jobevne is already available in Europe and Canada under the name Abevmy, following approvals in 2021.

Bevacizumab sales in the U.S. totaled approximately $2 billion in 2023, highlighting the potential market impact of Biocon’s entry.

Biocon Biologics, a global leader in biosimilars and insulin products, serves over 5 million patients annually. The company has achieved several industry firsts, including the first FDA-approved interchangeable biosimilar insulin, Semglee (insulin glargine). With a pipeline of 20 biosimilar assets under development across various therapeutic areas, Biocon continues to build on its vision of expanding global access to advanced biologics.

Comments (0)
Add Comment