……..catching up on FDA Approvals
The FDA recently approved a new infused therapy, Avzivi (bevacizumab-tnjn) from Bio-Thera Solutions, as a biosimilar to AVASTIN (bevacizumab). It did not receive an interchangeable designation.
Avzivi is indicated for the treatment of (refer to prescribing information for full indication):
- Metastatic colorectal cancer, in combination
- Metastatic colorectal cancer, in combination
- Non-squamous non-small cell lung cancer, in combination
- Recurrent glioblastoma in adults
- Metastatic renal cell carcinoma in combination
- Cervical cancer, in combination
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination.
CLICK HERE to access prescribing information
Four biosimilar versions of Avastin were previously approved:
- Mvasi (bevacizumab-awwb),
- Zirabev (bevacizumab-bvzr),
- Alymsys (bevacizumab-maly), and
- Vegzelma (bevacizumab-adcd).
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FDA Approves Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin
- Avzivi (BAT1706) is Bio-Thera Solutions’ second FDA approved product in the United States
- Avzivi® is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States
