Biocon Limited announced that its subsidiary Biocon Biologics has secured the approval from the United States Food and Drug Administration for Jobevne. It is a biosimilar for intravenous use.
Jobevne is a recombinant humanised monoclonal antibody that is used to treat several types of cancer. The product is a biosimilar to the reference product Avastine (bevacizumab), said the company.
Jobevne is a vascular endothelial growth factor (VEGF) impediment that sticks with VEGF and restrain the interaction with its receptors. This shall prevent angiogenesis, combating cancer by restricting blood supply to the tumour, it said.
With this approval, Biocon Biologics has enlarged its oncology portfolio in the United States, including Ogivri and Fulphila.
The US sales of bevacizumab was about $2 Billion in 2023. In the US markets some of the company’s competitors include Amgen, Amneal, Celltrion and Pfizer.
The company is also involved in marketing of bevacizumab in Europe and Canada under the name Abevmy. These drugs were approved in 2021.
The CEO and Managing Director of Biocon Biologics, Shreehas Tambe, stated that the company has received approval from the USFDA for Jobevne (bevacizumab-nwgd), it marks a significant milestone. It is company’s seventh biosimilar to receive approval in the United States. This is also a strong addition to pharma business’ robust oncology portfolio.
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