雙鷺藥業(002038.SZ):替米沙坦片通過仿製藥質量和療效一致性評價
格隆匯11月21日丨雙鷺藥業(002038.SZ)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於替米沙坦片《藥品補充申請批准通知書》,公司替米沙坦片(欣益爾®)通過仿製藥質量和療效一致性評價。
替米沙坦片主要用於原發性高血壓的治療,由德國勃林格殷格翰公司研發,1998年在美國上市。截止到目前國內生產企業超過30家,目前通過一致性評價的有9家。IQVIA數據庫顯示,2020年該藥品醫院採購金額為人民幣63,713萬元。該品種在2021年國家第四批集中招標採購中中標價(40mg)為12.89元-13.46元/28片/盒,平均降幅約70%,中標企業為北京福元醫藥股份有限公司、上海信宜天平藥業有限公司、宜昌東陽光長江藥業股份有限公司、江蘇亞邦愛普森藥業有限公司。
替米沙坦片通過一致性評價後將提升該產品的市場競爭力,但未來仍有一定的降價壓力。
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