Mylan, Biocon inch closer to Lantus copycat launch

FDA :2020年胰岛素将被重新归类为生物制剂,控制其仿制药的生产

2018-12-14 12:51:40 pharma

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Sanofi’s Lantus is already facing off against generic competition from Eli Lilly and Boehringer’s Basaglar, but now Mylan is adding to the pressure by prevailing in a patent challenge at the U.S. Patent and Trademark Office.  “In our opinion, if Samsung Bioepis and Merck can't make the economics work, then one should be skeptical of Mylan and Biocon having substantial success,” he added.  Pricing woes aside, Mylan and Biocon have already suffered a regulatory setback at the FDA after the agency documented manufacturing problems at a Biocon plant in Malaysia. Now, they've resubmitted their application. The partners have already secured European approval for the drug as Semglee.   Meanwhile, as Mylan and Biocon work to advance their product, the FDA is making its own moves to boost insulin competition. This week, FDA commissioner Scott Gottlieb said insulin prices are unacceptably high and that the agency will reclassify them as biologics in 2020 to help support biosimilar development and boost competition. Currently, insulins are classified as drugs; Gottlieb said this makes it difficult for companies to develop insulin copycats through the traditional generic pathway.
赛诺菲的 Lantus 已经面临来自 Eli Lilly 和 Boehringer 的 Basaglar 的仿制药竞争,但现在 Mylan 在美国专利和商标局的专利挑战中加大了普遍的压力。 “在我们看来,如果三星生物和默克不能让经济发挥作用,那么人们应该对 Mylan 和 Biocon 取得实质性成功持怀疑态度,”他补充道。 除了定价问题以外, Mylan 和 Biocon 在马来西亚的一家 Biocon 工厂记录了生产问题后,已经在 FDA 遭遇监管挫折。现在,他们重新提交了他们的申请。这些合作伙伴已经获得了 Semglee 在欧洲的批准。 与此同时,随着 Mylan 和 Biocon 努力推进他们的产品, FDA 正在采取自己的行动来促进胰岛素竞争。本周, FDA 专员 ScottGottlieb 说,胰岛素价格高得令人难以接受, FDA 将在2020年将其重新归类为生物制剂,以帮助支持生物类似物的发展并促进竞争。 目前,胰岛素被列为药物; Gottlieb 说,这使得公司很难通过传统的通用途径开发胰岛素仿制药物。

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