FDA Greenlights Bevacizumab Biosimilar in Multiple Solid Tumor Indications

Bevacizumab biosimilar Jobevne |

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The FDA has granted approval to bevacizumab-nwgd (Jobevne)—a biosimilar referencing bevacizumab (Avastin)—for the treatment of patients with a variety of solid tumors, including metastatic colorectal cancer (mCRC); unresectable, locally advanced, recurrent, or metastatic non-squamous cell non–small cell lung cancer (NSCLC); recurrent glioblastomas; metastatic renal cell carcinoma (mRCC); recurrent or metastatic advanced cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.1

The bevacizumab biosimilar is a recombinant humanized monoclonal antibody, and it is approved in the following indications:

• in combination with fluorouracil-based chemotherapy for first-or second-line treatment of patients with mCRC; and in combination with fluoropyrimidine and irinotecan– or fluoropyrimidine and oxaliplatin–based chemotherapy for second-line treatment in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen.
• in combination with carboplatin and paclitaxel for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC.
• for adult patients with recurrent glioblastoma.
• in combination with interferon alfa for patients with metastatic mRCC.
• in combination with paclitaxel and cisplatin or paclitaxel and topotecan for patients with persistent, recurrent, or metastatic cervical cancer.
• in combination with carboplatin and paclitaxel, followed by Jobevne alone, for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection; in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens; and in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Notably, Jobevne is not approved for the adjuvant treatment of patients with colon cancer.

“The FDA approval of Jobevne is a significant milestone—our seventh biosimilar approved in the United States and a strong addition to our robust oncology portfolio,” Shreehas Tambe, chief executive officer and managing director at Biocon Biologics, the developer of the bevacizumab biosimlar, stated in a news release. “It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.”

In March 2020, the FDA accepted a biologics license application (BLA) for the bevacizumab biosimilar and was set to be reviewed by the FDA with an action date of December 2020.2 However, in December 2020, the FDA deferred the BLA for the proposed biosimilar because of restrictions due to the COVID-19 pandemic.3

Safety and Warnings

Instances of adverse effects (AEs) associated with bevacizumab biosimilar use included gastrointestinal (GI) perforations and fistula. Treatment should be discontinued if patients experience GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation in any organ. For patients who experienced wound healing complications during treatment with Jobevne, the treatment should be withheld until the wound is adequately healed. The biosimilar should be withheld for at least 28 days before elective surgery, and it should not be administered for at least 28 days after a major surgery until the wound has adequately healed.

Severe or fatal hemorrhages have occurred with the bevacizumab biosimilar; it should not be administered for recent hemoptysis and should be discontinued for grade 3 or 4 hemorrhages. Blood pressure should be monitored for patients with hypertension and should be treated for hypertension; Jobevne should be withheld until hypertension is medically controlled and can be resumed thereafter. However, the biosimilar should be discontinued for hypertensive crisis or hypertensive encephalopathy.

Jobevne discontinuations should occur if patients experience arterial thromboembolic or venous thromboembolic events; posterior reversible encephalopathy syndrome; nephrotic syndrome; severe infusion-related reactions; and congestive heart failure. The use of the biosimilar could cause fetal harm or ovarian failure.

References

1. Biocon Biologics announces U.S. FDA approval for Jobevne, biosimilar bevacizumab, expanding its oncology portfolio. News Release. Biocon Biologics. April 10, 2025. Accessed April 10, 2025. https://www.bioconbiologics.com/biocon-biologics-announces-u-s-fda-approval-for-jobevne-biosimilar-bevacizumab-expanding-its-oncology-portfolio/
2. U.S. FDA accepts biologics license application (BLA) for Mylan and Biocon’s proposed biosimilar bevacizumab for review. News Release. Mylan. March 9, 2020. April 10, 2025. https://investor.mylan.com/news-releases/news-release-details/us-fda-accepts-biologics-license-application-bla-mylan-and-1.
3. Biocon Biologics statement on the status of bevacizumab FDA action date in Dec 2020. News Release. Biocon Biologics. December 25, 2020. Accessed April 10, 2025. https://www.biocon.com/biocon-biologics-statement-on-the-status-of-bevacizumab-fda-action-date-in-dec-2020/