Biocon Biologics Secures U.S. FDA Approval for Jobevne

Jobevne: Expanding Access to Affordable Cancer Treatment

🔬 Biocon Biologics Ltd, a subsidiary of Biocon Ltd, announced that the U.S. FDA has approved Jobevne™ (bevacizumab-nwgd), a biosimilar to Avastin®, marking its seventh biosimilar approval in the U.S. and further strengthening its oncology portfolio.

🌱 What is Jobevne™?
A VEGF inhibitor, Jobevne™ targets blood vessel growth (angiogenesis) in tumors — a vital therapy in treating several cancers including:

• Metastatic colorectal cancer
• Advanced non-small cell lung cancer
• Recurrent glioblastoma
• Cervical, renal cell, and ovarian cancers

🌍 Already approved in Europe and Canada as ABEVMY™, this approval reflects Biocon’s scientific depth and global biosimilar footprint. In the U.S. alone, bevacizumab sales touched $2.0B in 2023.

🗣️ Shreehas Tambe, CEO & MD, said:

“This is a significant milestone… and underscores our commitment to expanding access to high-quality, affordable biologics.”

💡 Biocon Biologics serves over 5 million patients annually, with 20+ biosimilar assets in development across oncology, immunology, diabetes, and more.

Source: https://www.biocon.com/biocon-biologics-announces-u-s-fda-approval-for-jobevne-biosimilar-bevacizumab-expanding-its-oncology-portfolio/

🎯 Approved Indications (FDA) Jobevne

Jobevne is approved to treat the following solid tumors:

• Metastatic colorectal cancer (first- and second-line, including fluorouracil-, irinotecan-, or oxaliplatin-based regimens)

• Unresectable/recurrent non-squamous non-small cell lung cancer (with carboplatin + paclitaxel)

• Recurrent glioblastoma

• Metastatic renal cell carcinoma (with interferon α)

• Persistent/recurrent/metastatic cervical cancer (with paclitaxel + cisplatin or topotecan)

• Epithelial ovarian/fallopian tube/primary peritoneal cancer, including:

  • With carboplatin + paclitaxel followed by Jobevne maintenance

  • With paclitaxel + pegylated liposomal doxorubicin/topotecan in platinum-resistant cases

  • With carboplatin + paclitaxel/gemcitabine for platinum‑sensitive disease

Important note: Not indicated for adjuvant treatment of colon cancer .

Jobevne is the sixth bevacizumab biosimilar approved in the U.S., following:

• Mvasi (Amgen, 2017)

• Zirabev (Pfizer, 2019)

• Alymsys (Amneal, 2022)

• Vegzelma (Celltrion, 2022)

• Avzivi (Sandoz, 2023)

#BioconBiologics #Jobevne #FDAApproval #Biosimilars #Oncology #AffordableHealthcare #BiotechIndia #ScienceNews #SciFocus