FDA Approved Avzivi, Marking The Fifth Biosimilar To Avastin

The FDA has approved Avzivi (bevacizumab-tnjn), the fifth biosimilar of bevacizumab developed by Bio-Thera Solutions, for the treatment of various cancer types.

Avzivi (bevacizumab-tnjn) is a humanized monoclonal antibody designed to target vascular endothelial growth factor (VEGF). Its precise mechanism involves binding specifically to VEGF, impeding its interaction with its receptor. This action results in the reduction of neovascularization, degradation of existing blood vessels, and consequent inhibition of tumor growth.

Indications OF Avzivi

Originally denoted as BAT1706, Avzivi holds FDA approval in the United States for several indications such as,

Metastatic Colorectal Cancer (First- or Second-Line Treatment):

Indicated in combination with intravenous fluorouracil-based chemotherapy.
Also indicated for second-line treatment in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for patients who have progressed on a first-line bevacizumab product-containing regimen (with a limitation of not being indicated for adjuvant treatment of colon cancer).

Non-Squamous Non-Small Cell Lung Cancer:

Recommended for unresectable, locally advanced, recurrent, or metastatic cases.
Indicated in combination with carboplatin and paclitaxel for first-line treatment.

Recurrent Glioblastoma (Adults):

Approved for treatment in adults.

Metastatic Renal Cell Carcinoma:

Recommended in combination with interferon alfa.

Cervical Cancer:

Indicated for persistent, recurrent, or metastatic cases.
Recommended in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer:

Indicated for platinum-resistant recurrent disease.
Recommended in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan.
Patients should have received no more than two prior chemotherapy regimens.

Biosimilars of Avastin are authorized for the treatment of cancers similar to those approved for Avastin, except liver cancer. Due to the specifics of its examination in clinical trials, Avastin alone holds approval for liver cancer treatment.

Distinguishing Avzivi from Other Biosimilars:

Avastin has notable biosimilars, including

Mvasi (bevacizumab-awwb)
Zirabev (bevacizumab-bvzr)
Alymsys (bevacizumab-maly)
Vegzelma (bevacizumab-adcd)
Avzivi (bevacizumab-tnjn)

Mvasi (bevacizumab-awwb)

Mvasi, the pioneering Avastin biosimilar, gained FDA approval in 2017, officially entering the U.S. market two years later.
Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

Zirabev (bevacizumab-bvzr)

On Friday, June 28, 2019, Pfizer Inc. announced the approval granted by the United States Food and Drug Administration (FDA) for Zirabev (bevacizumab-bvzr).
This approval signifies the second FDA-approved biosimilar of bevacizumab, following the prior approval of Mvasi (bevacizumab-awwb).

Alymsys (bevacizumab-maly)

On April 13, 2022, Amneal Pharmaceuticals, Inc. received FDA approval for its Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing Avastin.
Marketed as Alymsys, it is now the third FDA-approved bevacizumab biosimilar in the United States.

Vegzelma (bevacizumab-adcd)

On September 28, 2022, Celltrion USA revealed that the U.S. Food and Drug Administration (FDA) approved Vegzelma (bevacizumab-adcd).

Avzivi (bevacizumab-tnjn)

Avzivi, developed by Bio-Thera Solutions, stands out among biosimilars due to its distinctive attributes. Obtaining FDA approval on December 19, 2023, Avzivi adheres to a unique timeline.
The global phase 3 clinical trial has unequivocally affirmed Avzivi’s efficacy, safety, and immunogenicity, thereby establishing it with specific data.
As the fifth biosimilar to Avastin sanctioned in the United States, Avzivi commands a distinct regulatory status.
Avzivi distinguishes itself as a biosimilar to Avastin, aiming to offer a more economically viable treatment option for cancer patients.

Market Demand for Avastin:

Expected to undergo substantial expansion between 2023 and 2030, the global Avastin market, with North America, especially the United States, yielding significant sway, is poised for significant growth. This surge is propelled by a growing demand for Avastin, fueled by the proliferation of healthcare facilities, encompassing hospitals, ambulatory surgical centers, and clinics. Despite the historical zenith of sales reaching USD 2,321.70 million in 2022, a noteworthy historical contraction (CAGR) of 31% transpired from 2019 to 2022.

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