2022-04-20| Trials & Approvals

Alymsys Becomes the Third Biosimilar for Bevacizumab Approved by FDA

by Sahana Shankar
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Alymsys, a biosimilar for anti-angiogenic bevacizumab, has been approved by the U.S. FDA. Alymsys was developed by mAbxience and will be marketed by Amneal Pharmaceuticals. Alymsys is a concentrated solution for infusion with other chemotherapeutic agents, typically fluoropyrimidine-based drugs for colorectal cancer and paclitaxel for metastatic breast cancer. 

Alymsys was developed by a collaboration between Brand Institute, mAbxience and Amneal Pharmaceuticals. In a press release, Brand Institute’s Chairman and C.E.O., James L. Dettore said, “The entire Brand Institute and Drug Safety Institute Team congratulates Amneal Pharmaceuticals and mAbxience on the FDA approval of ALYMSYS.”

“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, Chief Executive Officer of mAbxience. 

Considering the usefulness of blocking vascularization in anti-cancer therapy, avastin has spurred the development of biosimilars. After Amgen’s Mvasi in 2017, Pfizer’s Zirabev in 2019, Alymsys is the third biosimilar to be approved for bevacizumab by the US FDA.  It was approved by the European Medicine Agency in 2021. 

Related Article: Innovent and Lilly Expand Strategic Partnership in Oncology 


Oncology Biosimilars Can Bring in Huge Revenues


Avastin/Bevacizumab was developed by Genentech and was first approved by the US FDA in 2004. It is a vascular endothelial growth factor inhibitor that is approved for treatment in many cancers, including metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, ovarian cancer, cervical cancer to starve the tumor by blocking the connecting blood vessels. Avastin was initially designed as a chemotherapy additive to prevent tumor growth. According to IQVIA, annual sales for bevacizumab (Feb 2021-2022) was $2.6 billion, with biosimilars contributing to $1.6billion, suggesting a robust market for biosimilars. 

Amneal, initially developed as a generics manufacturer in New Jersey, USA, has slowly moved toward biosimilars. This is Amneal’s second biosimilar approved this year, after RELEUKO, a biosimilar for Neupogen, a treatment for neutropenia, a common side effect of chemotherapy. Another biosimilar referencing Neulasta is currently under review. “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. 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.

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