Bevacizumab-maly has been approved by the FDA for multiple cancer indications, becoming the third FDA-approved bevacizumab biosimilar.

The FDA has approved bevacizumab’s (Avastin) second biosimilar, bevacizumab-maly (Alymsys), in a variety of cancer indications, according to a press release from Amneal Pharmaceuticals.1.2

The VEGF inhibitor’s approval is the second of 3 approvals developer Amneal expects in 2022.

“With the US approval of our second biosimilar, [bevacizumab-maly] we are building momentum and establishing our presence in the $28 billion US biosimilar market. By combining our partners’ assets with our own key capabilities, we are well on our way to becoming a significant player in this high-growth category. Biosimilars represent the next wave of affordable medicines in the United States and are closely aligned with our strategy to bring affordable, high-quality medicines to as many patients as possible,” said Chirag Patel and Chintu Patel, co-directors. generals of Amneal Pharmaceuticals, in a press release.

Bevacizumab-maly can be used in many tumor types, including:

The biosimilar has several warnings and precautions for several toxicities, including severe and fatal bleeding; arterial and venous thromboembolic events; hypertension, hypertensive crisis and hypertensive encephalopathy; kidney damage, proteinuria and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo-fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; and complications related to surgery/wound healing and infusion-related reactions. Additionally, treatment-related adverse events with bevacizumab-maly include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, impaired taste, dry skin and lacrimal disorders.

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

References

  1. Amneal obtains the second biosimilar approval in the United States with ALYMSYS® (bevacizumab-maly). Press release. April 13, 2022. Accessed April 19, 2022. https://bit.ly/3vrn67n
  2. FDA approves Alymsys® (bevacizumab-maly), a bevacizumab biosimilar by Amneal Pharmaceuticals, Inc., developed by mAbxience. Press release. April 18, 2022. Accessed April 19, 2022. https://prn.to/3jXmVeA

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