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Amneal obtains FDA nod for Avastin biosimilar

The product, which will be marketed under the proprietary name Alymsys, represents the third bevacizumab biosimilar approval.

The Food and Drug Administration has given Amneal permission for bevacizumab-maly. The medication, a biosimilar to Genentech's Avastin, will be marketed under the proprietary name Alymsys and represents the third bevacizumab biosimilar approval. 

“With the U.S. approval of our second biosimilar, Alymsys, we are continuing our momentum and establishing our presence in the $28 billion U.S. biosimilars market,” said Chirag and Chintu Patel, co-CEOs of Amneal. “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.”

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Alymsys was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture and commercialization of biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology.

“Through our strategic partnership with a market leader like Amneal, we are excited to see this important product enter the U.S. biosimilar market. For us, this is a great example of our globalization strategy materializing and how innovation and cutting-edge R&D technology can be applied to create high quality, affordable medicines that improve access to critical treatments,” said Emmanuelle Lepine, CEO of mAbxience.

Bevacizumab has a market value of $2.6 billion, $1.6 billion of which represented biosimilar sales, for the 12 months ending February 2022, according to IQVIA.

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Alymsys is a vascular endothelial growth factor inhibitor 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; and
  • Epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel.

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