在一个新的和更便宜的胰岛素冰壶的种族中，法律困难可能会推迟到市场上的新产品

你有没有想过为什么可以提供更便宜的“通用”胰岛素产品？这很快就会随着品牌胰岛素的专利而变化，开始过期。In fact, the patents for Sanofi’s top-selling Lantus (basal insulin glargine) are set to expire in the US in 2015, and other companies are racing to produce new “generic” insulins that could provide more choices for patients and importantly, push down the prices. The term “generic” traditionally applies to small molecules that are chemically and structurally equivalent to the original drug. Biosimilars created for products like insulin are biologically created products that tend to be more complex and sensitive. Thus it is difficult to completely prove that a biosimilar drug is identical to the original like a true “generic” drug.要了解有关“通用”胰岛素产品以及定义的更多信息，请继续阅读倾向＃26。

比赛已经开始了。12月20日，Eli Lilly and Boehringer Igelheim宣布向FDA提交新的基底胰岛素狼原油。该化合物称为LY2963016，是美国，欧洲和日本的监管审查。In January, we learned that Sanofi has filed a lawsuit against Lilly alleging patent violations of the original top-selling Lantus (insulin glargine) – the lawsuit could delay the FDA’s decision on drug approval for up to 30 months, which would push back potential approval to 2016. This is a bit of a surprise and we’re working on “unpacking” this to better understand the moves on each side.

其他公司也进入了游戏。默克和三星生物普西斯于二月宣布伙伴关系开发“通用”胰岛素狼藤甘油，并为候选人MK-1293的候选人的第3阶段测试将开始“很快”。基于印度的生物管也有自己的“通用”胰岛素狼狼产品，这些产品已经在世界各地的十多个国家批准，并在今年开始进行第3阶段审判。尽管法律事务周围的不确定性，但肯定有很多兴趣将胰岛素的胰岛素狼人延展到市场。-NL.