Biocon Biologics' Jobevne Gets FDA Approval, Targets $2B Market

Biocon Biologics Secures Key US FDA Approval

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has received approval from the U.S. Food and Drug Administration (FDA) for its biosimilar Bevacizumab, which will be marketed as Jobevne™ (Bevacizumab-nwgd). The approval, granted on April 10, 2025, is a significant milestone for the company, strengthening its oncology portfolio within the competitive United States market. This development positions Biocon Biologics to compete in the substantial market for Bevacizumab, which recorded approximately $1.0 billion in U.S. sales in 2023.

Understanding Jobevne and Its Role in Cancer Treatment

Jobevne is an intravenous recombinant humanised monoclonal antibody designed for the treatment of several types of cancer. As a biosimilar, it is highly similar to its reference product, Avastin® (Bevacizumab), with no clinically meaningful differences in terms of safety, purity, and potency. The drug functions as a vascular endothelial growth factor (VEGF) inhibitor. By binding to VEGF, it prevents the protein from interacting with its receptors, thereby inhibiting angiogenesis—the formation of new blood vessels that tumors need to grow and spread. The FDA's clearance was based on a comprehensive data package that demonstrated Jobevne's similarity to Avastin®, including pharmacokinetic, safety, efficacy, and immunogenicity data.

Expanding the US Oncology Portfolio

The approval of Jobevne marks the seventh biosimilar from Biocon Biologics to receive regulatory clearance in the U.S. It joins the company's existing U.S. oncology biosimilar offerings, which include OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The company also markets its bevacizumab biosimilar under the brand name ABEVMY in Europe and Canada, where it was approved in February 2021 and November 2021, respectively. Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., described the approval as a "milestone moment," emphasizing its strategic importance in bolstering their oncology franchise and advancing their mission to provide affordable, high-quality biologics.

| Biocon's Key US Oncology Biosimilars | | :--- | :--- | | Biosimilar Name | Reference Product | | OGIVRI (Trastuzumab-dkst) | Herceptin® | | FULPHILA (Pegfilgrastim-jmdb) | Neulasta® | | Jobevne™ (Bevacizumab-nwgd) | Avastin® |

Approved Indications and Safety Profile

Jobevne has been approved for a range of indications, including various forms of colon, rectal, lung, cervical, and kidney cancer. However, it is not recommended for the adjuvant treatment of colon cancer. The product's labeling includes important warnings and precautions regarding potential adverse effects, such as gastrointestinal perforations, issues with wound healing, hemorrhage, and hypertension, which are consistent with the known safety profile of bevacizumab.

A Strategic Journey: Preserve, Consolidate, Accelerate

This latest regulatory success is a direct outcome of Biocon Biologics' well-defined three-stage strategic plan. The first stage, 'Preserve,' focused on ensuring business continuity during the complex integration of Viatris's global biosimilars business, which was completed in November 2022. The 'Consolidate' phase followed, during which the company successfully integrated the acquired business ahead of schedule and surpassed the $1 billion annual revenue milestone by March 2024. The company has now entered the 'Accelerate' phase, which began in 2025. The launch of Jobevne in the U.S. is a key component of this acceleration, which aims to propel Biocon Biologics into the top three biosimilars companies globally.

Global Manufacturing and Commercial Reach

Biocon Biologics operates as a fully integrated global biosimilars company with a commercial presence in over 120 countries. Its end-to-end capabilities, from research and development to large-scale manufacturing, have been critical to its success. The company's manufacturing facilities in India and Malaysia meet stringent global regulatory standards. Recently, the European Medicines Agency (EMA) approved the company's Bengaluru facility for the manufacture of biosimilar Bevacizumab, adding significant capacity to meet growing demand in European markets. This facility had previously received approval for manufacturing Trastuzumab in September 2022.

Future Growth and Pipeline

With nine biosimilars already commercialized and a deep pipeline of 20 products in development, Biocon Biologics is poised for continued growth. The company plans to execute three global launches (bAflibercept, bUstekinumab, and bDenosumab) and five U.S. launches (bAspart, bBevacizumab, bAflibercept, bUstekinumab, and bDenosumab) over the next two to three years. These launches are expected to address a market opportunity of over $10 billion by FY27. The company's strategic partnerships, including the acquisition of Viatris's biosimilars business and distribution agreements with Sandoz, are crucial for expanding its commercial footprint and ensuring patient access to its medicines worldwide.

Conclusion

The FDA approval of Jobevne is a significant achievement for Biocon Biologics, reinforcing its position as a leading player in the global biosimilars industry. It not only expands the company's therapeutic offerings for cancer patients in the U.S. but also aligns perfectly with its strategic goal of accelerating growth and enhancing access to affordable, life-saving medicines. As Biocon Biologics continues to execute its launch plans and advance its pipeline, it remains focused on its mission to transform healthcare and improve patient outcomes globally.