FDA authorizes Biocon Biologics' cancer biosimilar bevacizumab

Biocon Biologics has achieved a notable milestone with the green light from the US Food and Drug Administration (FDA) for its drug, Jobevne (bevacizumab-nwgd). This medication is an intravenous biosimilar to the already established Avastin (bevacizumab), primarily utilized in cancer treatment. Jobevne functions as a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor, effectively targeting cancer by restricting the blood supply to tumors.

This FDA approval significantly enhances Biocon Biologics' oncology portfolio in the United States, a portfolio that already includes treatments such as Fulphila (Pegfilgrastim-jmdb) and Ogivri (Trastuzumab-dkst). Beyond the US, Biocon Biologics has been marketing bevacizumab under the brand name Abevmy in Europe, having received approval there in February 2021, followed by approval in Canada in November of the same year.

The FDA's endorsement of Jobevne was underpinned by a comprehensive set of data, including comparative studies on pharmacokinetics, efficacy, nonclinical and functional aspects, and safety, as well as analytical and structural data. This extensive research demonstrated that Jobevne closely mirrors its reference product in these areas. Importantly, the findings showed no significant clinical differences between Jobevne and Avastin regarding safety, efficacy, immunogenicity, and pharmacokinetics.

Shreehas Tambe, CEO and managing director of Biocon Biologics, emphasized the importance of this achievement, noting that Jobevne is the seventh biosimilar from Biocon to gain approval in the US. He highlighted the company's commitment to scientific excellence and the aim to provide high-quality, affordable biologics. Tambe expressed anticipation in collaborating with various stakeholders to expand treatment options available to patients.

Biocon Biologics' reach extends beyond the US, as the company has commercialized nine biosimilars across markets in the US, Australia, Canada, Japan, and Europe. This is part of a larger pipeline comprising 20 products, with a focus on oncology, ophthalmology, immunology, diabetology, and other non-communicable diseases.

In an additional strategic move, Biocon Biologics entered into a settlement and license agreement in August 2024 with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen). This agreement pertains to the commercialization of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara, further exemplifying Biocon's dedication to expanding its biosimilar offerings and reinforcing its position in the global pharmaceutical landscape.