Pune, India | September 16, 2025
Biocon Biologics has reached a key milestone by securing U.S. Food and Drug Administration (FDA) approval for its cancer treatment biosimilar, Jobevne™ (bevacizumab-nwgd). This biosimilar is modeled after the popular cancer drug Avastin®. Consequently, the FDA’s approval marks an important advancement for Biocon’s oncology portfolio. Moreover, it reinforces the company’s mission to provide affordable, high-quality biologic medicines worldwide. With this approval, Biocon now has seven biosimilars authorized for the U.S. market.
Jobevne works by targeting vascular endothelial growth factor (VEGF). VEGF is a protein that tumors use to stimulate the growth of new blood vessels needed for their expansion. By blocking VEGF, Jobevne disrupts the tumor’s blood supply and slows tumor growth. To gain FDA approval, Biocon conducted an extensive clinical trial program. These trials demonstrated that Jobevne is highly similar to Avastin. They tested structural similarity, pharmacokinetics, efficacy, safety, and immune responses. Importantly, the results met the FDA’s strict requirements, confirming Jobevne’s clinical equivalence to Avastin.
The FDA approved Jobevne for multiple cancer types. These include metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, and several ovarian and peritoneal cancers. However, the approval does not include adjuvant treatment for colon cancer. Despite this exception, the broad range of indications makes Jobevne a valuable option. Therefore, it can expand affordable oncology treatment choices for physicians and patients alike.
Biocon already sells bevacizumab under the brand name Abevmy in Europe and Canada. Launching Jobevne in the U.S. helps strengthen the company’s position in one of the largest biosimilar markets worldwide. This is notable as bevacizumab generated nearly $2 billion in sales in the U.S. in 2023. Consequently, introducing a biosimilar like Jobevne can lower treatment costs, improve patient access, and ease financial pressures on healthcare systems.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, called the FDA approval a major achievement. He said the success reflects Biocon’s strong scientific capabilities. Furthermore, it shows their commitment to making biologic therapies more accessible globally. Tambe added that the approval improves Biocon’s credibility in developing and delivering complex biologics across international markets.
This approval also has wider implications for the U.S. biosimilar industry. It shows how companies like Biocon can navigate regulatory hurdles effectively. Indeed, it proves the safety and reliability of biosimilars. As a result, this success may encourage more biosimilar entries, which could lower prices and increase treatment availability.
After the announcement, Biocon’s share price rose by over 5 percent. This reflects positive investor confidence in the company’s biosimilar-focused growth strategy. Currently, Biocon serves over five million patients each year. Additionally, its robust pipeline includes 20 biosimilar candidates in areas such as diabetes, oncology, and immunology.
Looking ahead, Biocon will focus on quickly commercializing Jobevne. Priorities include efficient manufacturing, wide distribution, and collaboration with healthcare providers and insurers to support patient access. The U.S. market will soon show how well Jobevne competes with other approved bevacizumab biosimilars.
In summary, the FDA approval of Jobevne is a landmark for Biocon Biologics. It increases the company’s presence in the U.S. oncology market and brings affordable cancer care closer to thousands of patients. With strong leadership, a growing product pipeline, and expanding global reach, Biocon continues to lead innovation in biologic therapies worldwide.
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