Amneal, mAbxience's Biologics Licensing Application for Denosumab Biosimilars Accepted for Review by FDA

MT Newswires Live03-04

Amneal Pharmaceuticals (AMRX) and Fresenius Kabi's mAbxience unit said Monday that the US Food and Drug Administration accepted for review their biologics licensing application for two proposed denosumab biosimilars.

Denosumab is a monoclonal antibody that inhibits bone resorption and is used to treat conditions such as osteoporosis and bone metastases from cancer.

The US regulator has set a target action date in Q4, according to the companies.

Amneal has exclusive commercialization rights for the biosimilars in the US, while mAbxience is responsible for development and manufacturing, they added.

Amneal currently markets three biosimilars in the US and aims to expand its portfolio to six biosimilars across eight product presentations by 2027.

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