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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。