FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly

Amneal Pharmaceuticals Wednesday said the FDA approved the company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing the originator product (Avastin).

Amneal said the product will be sold under the name Alymsys. It is the third bevacizumab biosimilar approved in the United States, and the second of 3 US biosimilars the company expects to see approved this year.

Earlier this year, Amneal received approval of filgrastim-ayow (Releuko) which references Neupogen. The firm’s pegfilgrastim biosimilar referencing Neulasta is currently under FDA review.

Bevacizumab-maly was developed by mAbxience. The vascular endothelial growth factor inhibitor is 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 product-containing regimen
• First-line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel
• 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

Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.