Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

 Denosumab biosimilar candidates reference Prolia® and XGEVA®

Amneal looks to expand portfolio to six biosimilars across eight product presentations by 2027

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and mAbxience ("mAbxience") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia® and XGEVA®. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius.

The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027.

https://finance.yahoo.com/news/amneal-bla-submissions-two-denosumab-210500377.html