FDA Approves Amneal’s Avastin Biosimilar

FDA Approves Amneal’s Avastin Biosimilar

The FDA has approved Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly) as a biosimilar of Roche’s blockbuster cancer drug Avastin.

The biosimilar was developed by mAbxience and licensed to Roche’s subsidiary Genentech in 2018 for supplying to the U.S. market.

This is Amneal’s second biosimilar approval in 2022. The FDA approved Releuko (filgrastim-ayow), its biosimilar of Amgen’s white blood-cell booster Neupogen (filgrastim) earlier this year. And the agency is currently reviewing the company’s biosimilar of another Amgen bone marrow stimulant drug, Neulasta (pegfilgrastim).

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.

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.

April 20, 2022

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