Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, announced on April 10, 2025, that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd), a biosimilar to Roche's Avastin® (bevacizumab) for intravenous use in multiple cancer indications.
JOBEVNE is a recombinant humanized monoclonal antibody that functions as a vascular endothelial growth factor (VEGF) inhibitor. By binding to VEGF and blocking its interaction with receptors, the drug prevents angiogenesis—effectively combating cancer by restricting blood supply to tumors.
Expanding Oncology Portfolio
The approval marks Biocon Biologics' seventh biosimilar approved in the U.S. and strengthens its oncology portfolio, which already includes OGIVRI (trastuzumab-dkst) and FULPHILA (pegfilgrastim-jmdb). The company also markets bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, highlighted the significance of this approval: "The U.S. FDA approval of JOBEVNE™ 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."
Comprehensive Clinical Data Package
The FDA approval was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical, and functional data. These studies confirmed that JOBEVNE is highly similar to Avastin® with no clinically meaningful differences in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
Multiple Cancer Indications
JOBEVNE has been approved for multiple cancer indications, including:
- Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment
- Non-squamous non-small cell lung cancer that is unresectable, locally advanced, recurrent, or metastatic
- Recurrent glioblastoma in adults
- Metastatic renal cell carcinoma
- Persistent, recurrent, or metastatic cervical cancer
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer in various treatment settings
Market Opportunity
According to Biocon Biologics' analysis of IQVIA 2023 data, bevacizumab sales in the U.S. reached approximately $2.0 billion in 2023, representing a significant market opportunity for the company.
Safety Considerations
The FDA approval includes important warnings and precautions for JOBEVNE, including risks of gastrointestinal perforations, surgery and wound healing complications, hemorrhage, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury, infusion-related reactions, and embryo-fetal toxicity.
Biocon Biologics' Growing Biosimilar Presence
Biocon Biologics has established itself as a leading global player in biosimilars and insulin production. The company serves over 5 million patients annually across more than 120 countries and has achieved several "firsts" in the biosimilar industry, including the first approval of a trastuzumab biosimilar in the United States and the first U.S. approval of an interchangeable biosimilar insulin glargine (SEMGLEE).
The company's pipeline includes 20 biosimilar assets spanning multiple therapy areas, including diabetology, oncology, immunology, and ophthalmology. This robust development pipeline positions Biocon Biologics to continue expanding access to affordable biological therapeutics globally.
With this latest approval, Biocon Biologics continues to advance its mission of transforming healthcare by enabling affordable access to high-quality biosimilars while leveraging cutting-edge science, innovative technology platforms, global manufacturing capabilities, and world-class quality systems.
