Amneal secures second US biosimilars approval

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Olivier Le Moal
© GettyImages/Olivier Le Moal

Related tags: Avastin, Amneal Pharmaceuticals, Cancer, Biosimilars

Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.

The biosimilar drug will be marketed under the proprietary name Alymsys and represents the third bevacizumab biosimilar approved in the US.

Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology. US annual sales for bevacizumab for the 12 months ended February 2022 were US$2.6bn, with biosimilar sales of the drug hitting US$1.6bn, according to data released by IQVIA.

The authorization also marks the second of three biosimilars for which New Jersey headquartered Amneal expects to receive US approval in 2022 in oncology, the second-largest biosimilar category in the US. Earlier this year, Amneal received approval of Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen, and its pegfilgrastim biosimilar referencing Neulasta is currently under review by the FDA.

Tie-up with mAbxience

Alymsys was developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.

In 2018, Amneal entered into a licensing agreement with mAbxience for the US market for its bevacizumab biosimilar candidate. As part of that deal, mAbxience was responsible for clinical development and subsequent manufacture of the drug, while Amneal was to guide the product through regulatory approval, with it gaining exclusive commercialization rights in the US.

“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 US 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-CEOs, Amneal.

Bevacizumab is a humanized monoclonal antibody treatment for several cancers. It inhibits angiogenesis, the formation of new blood vessels, by blocking the action of vascular endothelial growth factor A (VEGF-A), thus it is said to slow the growth of new blood vessels in tumors. In the US it is approved for use in the treatment of colorectal, cervical, glioblastoma, kidney, ovarian, and certain lung cancers.

Related topics: Markets & Regulations, Biosimilars

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