Biocon Shares in Focus, Strengthens US Oncology Footprint with Biosimilar Approval

Biocon Biologics Ltd (BBL), a Biocon Ltd subsidiary, has received approval from the U.S. Food and Drug Administration (FDA) for its biosimilar Bevacizumab, marketed as Jobevne™ (Bevacizumab-nwgd). This milestone represents a major addition to the company's oncology portfolio in the United States market. The regulatory approval, received on April 10, 2025, places Biocon Biologics in a position to exploit the large market for Bevacizumab, which registered around $2.0 billion in sales in the U.S. in 2023.

Jobevne is an intravenous recombinant humanised monoclonal antibody and is used for the treatment of several cancers. Being a biosimilar, it replicates the mechanism of action of the reference product Avastin® (Bevacizumab). Jobevne acts as an inhibitor of vascular endothelial growth factor (VEGF), where it binds to VEGF to prevent it from interacting with receptors, thus inhibiting angiogenesis – the development of new blood vessels needed by tumours to grow.

The FDA clearance was supported by a robust set of comparative data, including pharmacokinetic, safety, efficacy, nonclinical, structural, analytical, and functional data, evidencing high similarity of Jobevne to Avastin®. The data established that there were no clinically significant differences between the two products with regard to pharmacokinetics, safety, efficacy, and immunogenicity.

This approval expands Biocon Biologics' current biosimilar oncology portfolio in the U.S., which currently consists of OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The firm also sells its bevacizumab biosimilar as ABEVMY in Europe (approved February 2021) and Canada (approved November 2021).

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., termed the approval as a "milestone moment", marking the seventh biosimilar to be given regulatory approval by the company in the U.S. He went on to underline its strategic value in enhancing their strong oncology portfolio and again underlined the company's goal of increasing access to high-quality, affordable biologics.

Jobevne has been approved for a range of indications including:

• Metastatic colorectal cancer under certain chemotherapy regimens for first- or second-line therapy and for second-line therapy following disease progression on a bevacizumab-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with certain chemotherapies for first-line therapy.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic advanced cervical cancer in combination with certain chemotherapies.
• Specific indications for epithelial ovarian, fallopian tube, or primary peritoneal cancer in various stages and treatment settings.

Jobevne is not recommended for the adjuvant treatment of colon cancer. The labeling information also details a number of warnings and precautions concerning possible adverse effects, such as gastrointestinal perforations, wound healing disturbances, haemorrhage, thromboembolic occurrences, hypertension, etc.

Biocon Biologics occupies a front-ranking position in biosimilars and insulin manufacturing globally. With its end-to-end 'lab to market' strengths, Biocon Biologics enables wide access to affordable biosimilars in more than 120 countries. Biocon Biologics' third USFDA approval reinforces its expansion efforts into pivotal international markets, further establishing it in the global biosimilars arena. The company has nine biosimilars that are currently commercialized and have a pipeline of 20 products in development across numerous therapeutic domains.

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