Amgen Gets FDA Approval for J&J/Merck's Remicade Biosimilar

FDA批准安进(Amgen)的Remicade治疗中重度类风湿关节炎

2019-12-10 09:02:01 YAHOO!FINANCE

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Amgen AMGN announced that the FDA has granted approval to its biosimilar version of Johnson and Johnson JNJ/Merck’s MRK blockbuster immunology medicine, Remicade . The biosimilar will be marketed by the trade name of Avsola  for all approved indications of Remicade, which includes a range of autoimmune disorders. ABP 710 is an anti-TNF monoclonal antibody. However, Amgen did not mention when it plans to launch Avsola. The approval was based, in part, on data from a late-stage study, which evaluated ABP 710 versus branded Remicade, for the treatment of moderate-to-severe rheumatoid arthritis (RA). Data from the phase III study showed that ABP 710 was non-inferior compared to Remicade based on its primary endpoint, which was assessment of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22. ABP 710 is also under review in the EU. Pfizer PFE was the first company to have launched a biosimilar version of Remicade, Inflectra in 2016. Merck/Samsung Bioepis also market Renflexis, a biosimilar of Remicade. Amgen’s shares have risen 20.1% this year so far compared with 6.6% increase registered by the industry during this period. Amgen boasts a strong biosimilars portfolio/pipeline, which could be an important long-term growth driver for the company. Amgen achieved several important milestones with its biosimilars portfolio in 2018/2019 including its first two launches in EU – Amjevita (biosimilar of AbbVie’s Humira) and Kanjinti (biosimilar of Roche’s Herceptin) as well as United States -  Kanjinti and Mvasi (biosimilar of Roche’s Avastin). In the United States, Amjevita is expected to be launched in the United States in 2023. Avsola is Amgen’s fourth biosimilar product to be approved in the United States. A biosimilar of Alexion’s Soliris (ABP 959) is in late state development. Amgen’s biosimilars business is already annualizing at approximately $700 million in sales .Amgen expects to launch additional biosimilars in 2020 across multiple geographies. Amgen has collaborated with Allergan for the worldwide development and commercialization of Mvasi, Kanjinti and biosimilar Rituxan (in late-stage development). Amgen has also tied up with Daiichi Sankyo for the commercialization of nine biosimilars in Japan. Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The Hottest Tech Mega-Trend of All                 Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early. See Zacks' 3 Best Stocks to Play This Trend >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research
安进(Amgen) AMGN 宣布, FDA 已批准其生物仿制药 Johnson 和 Johnson JNJ / Merck 的 MRK 重磅炸弹免疫学药物 Remicade 。该生物生物仿制药物将由 Avsola 的商品名销售,用于所有已批准的 Remicade 适应症,包括一系列自身免疫性疾病。ABP710是一种抗 TNF 单克隆抗体。然而,安进(Amgen)在计划推出 Avsola 时没有提及。 该批准部分基于后期研究的数据,该研究评估了 ABP710与品牌 Remicade 治疗中重度类风湿关节炎( RA )。第三阶段研究的数据显示, ABP710与 Remicade 相比并不差,因为它的主要终点是22周美国风湿学会核心集合测量( ACR20)20改善20%。 欧洲联盟也在审查 ABP710。辉瑞(Pfizer) PFE 是第一家在2016年推出 Remicade , Infectra 生物仿制药的公司。默克公司/三星生物制药也销售雷米卡的生物生物仿制药物 Renfluis 。 安进(Amgen)的股价今年迄今已上涨20.1%,而同期该行业的股价涨幅为6.6%。 安进(Amgen)拥有强大的生物仿制药产品组合/管道,这可能是该公司长期增长的重要推动力。安进(Amgen)在2018/2019年实现了其生物仿制药产品组合的几个重要里程碑,包括其在欧盟的首次两次上市—— Amjevita (艾伯维(AbbVie)的 Humira 的生物仿制药)和 Kanjinti ( Roche 的 Herceptin 的生物仿制药)以及美国的 Kanjinti 和 Mvasi (罗氏(Roche)的 Avastin 的生物仿制药)。在美国,预计将于2023年在美国发射 Amjevita 。Avsola 是安进(Amgen)在美国批准的第四个生物生物仿制药产品。亚力兄(Alexion)公司 Solris ( ABP959)的一种生物生物仿制药物正处于后期开发阶段。 安进(Amgen)的生物仿制药业务已实现年销售额约7亿美元。安进(Amgen)预计将在2020年在多个地区推出更多的生物仿制药。 安进(Amgen)公司与艾尔建(Allergan)公司合作开发 Mvasi 、 Kanjinti 公司和生物生物仿制药物 Rituxan 公司的全球开发和商业化(处于后期开发阶段)。安进(Amgen)还与第一三共(Daiichi Sankyo)合作,在日本商业化生产9种生物仿制药类似物。 安进(Amgen)目前拥有 Zacks 排名第3(保持)。你可以看到今天的 Zacks #1排名( Strong Buy )股票的完整列表。 热测技术大趋势 去年,它在全球创造了240亿美元的收入。到2020年,预计将突破屋顶,达到776亿美元。著名投资者 MarkCuban 表示,它将制作“世界上第一个三万亿张”,但这仍将为早期进行正确交易的普通投资者留下大量资金。 请参阅 Zacks 的3个最佳股票来玩这个趋势> 想要 Zacks 投资研究公司的最新建议吗?今天,你可以下载7个最佳股票的未来30天。点击获取此免费报告辉瑞(Pfizer)公司( PFE ):免费股票分析报告默克(Merck)公司( MRK ):免费股票分析报告强生公司( JNJ ):免费股票分析报告安进(Amgen)公司( AMGN ):免费股票分析报告阅读本文关于 Zacks 。com 点击这里。Zacks 投资研究

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