Biocon Biologics has gained approval from the US Food and Drug Administration (FDA) for the intravenous use of Jobevne (bevacizumab-nwgd), a biosimilar to the reference Avastin (bevacizumab).
Jobevne is a recombinant humanised monoclonal antibody which functions as a vascular endothelial growth factor inhibitor, targeting the cancer and restricting the supply of blood to tumours.
The approval bolsters the company’s biosimilar oncology portfolio in the US, which includes Fulphila (Pegfilgrastim-jmdb) and Ogivri (Trastuzumab-dkst).
The company has been marketing bevacizumab under the name Abevmy in Europe, where it was approved in February 2021. It also gained approval in November of the same year in Canada.
The FDA approval was supported by a comprehensive package comprising comparative pharmacokinetic, efficacy, nonclinical, functional, safety, analytical and structural data that demonstrated Jobevne’s high similarity to the reference product.
In safety, efficacy, immunogenicity and pharmacokinetics, the data showed no clinically meaningful differences between Jobevne and Avastin.
Biocon Biologics CEO and managing director Shreehas Tambe stated: “The US 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.”
Biocon Biologics has commercialised nine biosimilars from a pipeline of 20 products in the US, Australia, Canada, Japan and Europe.
Its development pipeline of biosimilar assets spans oncology, ophthalmology, immunology, diabetology and other non-communicable conditions.
In August 2024, the company reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (together called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara.
