U.S. License Holder:

Bio-Thera Solutions / Sandoz

Date of License:

December-06-2023

FDA-Approved Indications

---

AVZIVI (bevacizumab-tnjn) is a vascular endothelial growth factor inhibitor 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 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 cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan;

Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

Approved Foreign Follow-On Biologics / Biosimilars

---

Biosimilars Approved In The E.U.

Avzivi® (Bio-Thera Solutions) (July-2024)