On 9 April 2025, the US Food and Drug Administration (FDA) has approved Biocon’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab referencing Roche’s Avastin, for intravenous (IV) use.
Bevacizumab is a recombinant humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels (prevents angiogenesis) in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [1].
Jobevne (bevacizumab-nwgd) will be available for IV injections in 100 mg/4 mL and 400 mg/16 mL, and is indicated for:
- 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
The product has the limitation that it is not indicated for adjuvant treatment of colon cancer.
The approval of Jobevne expands Biocon Biologics’ biosimilar oncology portfolio in the US, which also includes Ogivri (trastuzumab-dkst) and Fulphila (pegfilgrastim-jmdb). In the U.S., sales of bevacizumab were approximately US$2.0 billion in 2023.
In Europe and Canada, the product is marketed as Abevmy [2, 3] and has already reached the market. Now, Jobevne joins other biosimilars of bevacizumab approved in the US, such as Bio-Thera Solutions’ Avzivi [4, 5].
By the end of April 2025, there were six and nine bevacizumab biosimilars approved in the US and Europe, respectively.
Related article
EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 22]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biocon to commercialize biosimilars in 31 European countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 22]. Available from: www.gabionline.net/pharma-news/biocon-to-commercialize-biosimilars-in-31-european-countries
3. GaBI Online - Generics and Biosimilars Initiative. Canada approves five biosimilars in last seven months [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 22]. Available from: www.gabionline.net/biosimilars/news/canada-approves-five-biosimilars-in-last-seven-months
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of biosimilar bevacizumab Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 22]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-biosimilar-bevacizumab-avzivi
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
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