FDA Approves Another Bevacizumab Biosimilar, Bevacizumab-maly

The FDA has granted approval to the biologics license application for bevacizumab-maly, a biosimilar of bevacizumab.

The FDA has granted approval to the biologics license application for bevacizumab-maly (Alymsys), making it the third biosimilar of bevacizumab (Avastin) approved in the United States, according to a press release by Amneal Pharmaceuticals, Inc.1

Bevacizumab was first granted approval by the FDA in 2004 in combination with chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC). Other FDA approvals followed for patients with nonsquamous non–small cell lung cancer (NSCLC), glioblastoma, metastatic renal cell carcinoma (RCC), and cervical cancer.2

Bevacizumab-maly is a vascular endothelial growth factor inhibitor. Mirroring the indications for bevacizumab, bevacizumab-maly is approved to treat patients with mCRC, in combination with intravenous fluorouracil-based chemotherapy in the first- or second-line setting, and mCRC in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in those who have progressed on a first-line bevacizumab product regimen.

In lung cancer, bevacizumab-maly is approved as a first-line therapy for non-squamous NSCLC in combination with carboplatin (Paraplatin) and paclitaxel (Abraxane).

Bevacizumab-maly is also indicated for the treatment of recurrent glioblastoma in adults; metastatic RCC in combination with interferon alfa, as well as persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin (Platinol) or paclitaxel and topotecan (Hycamtin); and epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel.

“With the US approval of our second biosimilar, Alymsys, we are continuing our momentum and establishing our presence in the $28 billion U.S. biosimilars market. By combining partner assets with our own key capabilities, we are on a clear path to becoming a meaningful player in this high growth category. Biosimilars represent the next wave of affordable medicines in the U.S. and are closely aligned with our strategy to provide high quality, affordable medicines to as many patients as possible,” said Chirag and Chintu Patel, co-chief executive officers, in a statement.

Considering its biosimilarity to bevacizumab, bevacizumab-maly, common adverse events to be expected include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis. Label warnings for the biosimilar may include perforation or fistula, arterial thromboembolic events, venous thromboembolic events, hypertension, Posterior Reversible Encephalopathy Syndrome, proteinuria, infusion reactions, and ovarian failure.


1. Amneal achieves second U.S. biosimilars approval with ALYMSYS® (bevacizumab-maly). News release. Amneal Pharmaceuticals, Inc. April 13, 2022. Accessed April 18, 2022. https://bit.ly/3xBu7oV

2. AVASTINâ (bevacizumab). FDA.gov. Accessed April 18, 2022. https://bit.ly/3rzIlmr

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