Sandoz Settles Patent Dispute With Amgen Related To Bone Disorder Drug Denosumab
Sandoz Settles Patent Dispute With Amgen Related To Bone Disorder Drug Denosumab
Generic and biosimilar manufacturer Sandoz AG (OTC:SDZNY) (OTC:SDZXF) reached an agreement on Tuesday with Amgen Inc (NASDAQ:AMGN) to resolve all patent litigation related to its U.S. denosumab biosimilars.
仿製藥和生物仿製藥製造商山德士股份公司（場外交易代碼：SDZNY）（場外交易代碼：SDZXF）週二與安進公司（納斯達克股票代碼：AMGN）達成協議，以解決與其美國denosumab生物仿製藥有關的所有專利訴訟。
Sandoz said in a statement that the agreement clears the way for the launch of denosumab biosimilars Jubbonti and Wyost on May 31, 2025, or earlier under certain circumstances.
桑多斯在一份聲明中表示，該協議爲2025年5月31日或在某些情況下更早推出denosumab生物仿製藥Jubbonti和Wyost掃清了道路。
"The terms of the agreement will not impact our previously disclosed 2024 guidance," Sandoz said.
桑多斯說：“協議條款不會影響我們先前披露的2024年指導方針。”
Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti and Wyost, on March 5, 2024.
山德士於2024年3月5日獲得美國食品藥品管理局對第一種也是唯一的denosumab生物仿製藥Jubbonti和Wyost的批准。
Jubbonti and Wyost are interchangeable with and approved by the FDA for all indications of reference medicines Prolia and Xgeva.
對於參考藥物Prolia和Xgeva的所有適應症，Jubbonti和Wyost可以互換並獲得美國食品藥品管理局的批准。
They have the same dosage form, route of administration, dosing regimen, and presentation as the respective reference medicines.
它們與相應的參考藥物具有相同的劑型、給藥途徑、給藥方案和外觀。
Denosumab is a human monoclonal antibody used for osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.
Denosumab 是一種人類單克隆抗體，用於骨質疏鬆症、治療誘導的骨質流失、骨轉移和骨鉅細胞腫瘤。
Patent infringement proceedings were initially filed by Amgen in the U.S. Federal District Court for the District of New Jersey in May 2023, the statement said.
聲明稱，專利侵權訴訟最初是由安進於2023年5月在美國新澤西特區聯邦地方法院提起的。
The litigation was resolved, followed by Sandoz's defense against Amgen's claims that the company infringed on up to 21 patents expiring as late as 2037, protecting reference medicines Prolia and Xgeva.
訴訟得到了解決，隨後Sandoz對安進的指控進行了辯護，安進指控該公司侵犯了多達21項專利，這些專利保護了參考藥物Prolia和Xgeva，這些專利最遲將於2037年到期。
In January, the FDA added a serious warning to the prescribing information for Amgen's drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific patient groups.
1月，美國食品藥品管理局在安進藥物Prolia（denosumab）的處方信息中增加了嚴重警告，強調特定患者群體鈣水平嚴重低的風險增加。
The boxed warning was implemented following a 2022 review into the risk of very low blood calcium in patients with advanced chronic kidney disease, particularly those undergoing dialysis while using Prolia.
該盒裝警告是在2022年對晚期慢性腎臟病患者，尤其是使用Prolia時接受透析的患者，血鈣極低的風險進行審查後實施的。
Price Action: AMGN shares are trading lower by 0.91% at $273.86 at the last check Tuesday.
價格走勢：在週二的最後一次支票中，AMGN股價下跌0.91％，至273.86美元。
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譯文內容由第三人軟體翻譯。