Jobevne FDA Approval History

Last updated by Judith Stewart, BPharm on April 15, 2025.

FDA Approved: Yes (First approved April 9, 2025)
Brand name: Jobevne
Generic name: bevacizumab-nwgd
Dosage form: Injection
Company: Biocon Biologics Ltd.
Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Jobevne (bevacizumab-nwgd) is a vascular endothelial growth factor inhibitor biosimilar to Avastin used for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

• Jobevne is indicated for the treatment of:
  - metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment.*
  - metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.*
  - unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
  - recurrent glioblastoma in adults.
  - metastatic renal cell carcinoma in combination with interferon alfa.
  - persistent, recurrent, or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
  - Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
  • in combination with carboplatin and paclitaxel, followed by Jobevne as a single agent, for stage III or IV disease following initial surgical resection
  • in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens
  • in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for platinum-sensitive recurrent disease.
  * Jobevne is not indicated for adjuvant treatment of colon cancer.
• FDA approval of Jobevne was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that Jobevne is highly similar to Avastin (bevacizumab). The data demonstrated that there were no clinically meaningful differences between Jobevne and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
• Jobevne is administered via intravenous infusion over 90 minutes for the first infusion, over 60 minutes for the second infusion if the first infusion is tolerated, and over 30 minutes for subsequent infusions if the second infusion over 60 minutes is tolerated.
• Warnings and precautions associated with Jobevne include gastrointestinal perforations and fistula; surgery and wound healing complications; hemorrhage; arterial and venous thromboembolic events; hypertension; posterior reversible encephalopathy syndrome; renal injury and proteinuria; infusion-related reactions; embryo-fetal toxicity; ovarian failure; and congestive heart failure.
• Common adverse reactions include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
• Jobevne is the sixth FDA approved biosimilar for Avastin following Mvasi (bevacizumab-awwb) in 2017, Zirabev (bevacizumab-bvzr) in 2019, and Alymsys (bevacizumab-maly) and Vegzelma (bevacizumab-adcd) in 2022, and Avzivi (bevacizumab-tnjn) in 2023.

Development timeline for Jobevne

Further information

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