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FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly
Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.
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.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
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Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
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Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
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Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.
