EU recommends approval of the first insulin bio generic

Source: DXY on July 1, 2014, the European Drug Administration announced that CHMP had adopted a positive opinion to recommend and approve the listing of nosiphyllis (insulin glargine) biosimilars jointly developed by Lilly and Boehringer Ingelheim Ly2963016, which will be marketed under abasia's trade name, is the first insulin biosimilars recommended for approval in the European Union, Lilly said Lilly said the CHMP recommendation is based on a non clinical and clinical development project that includes pharmacokinetic and pharmacodynamic studies, as well as phase 3 studies in patients with type 1 and type 2 diabetes If approved, abasia will become the fourth diabetes product approved in Europe by Lilly and the bringer Ingelheim diabetes alliance since its establishment in 2011 It came with 5.7 billion euros ($7.8 billion) in sales last year and will lose patent protection in Europe in 2015 However, Deutsche Bank analyst Clark said that sales of the product in Europe did not exceed 15% of its total sales in 2013, because the price of the drug was much lower than that in the United States, where sales accounted for about two-thirds of its total sales "It's less likely that there's a need to switch to cheaper generic drugs in Europe," Clark said, adding that this could curb the decline in sales in Europe at the time of arrival At the same time, although the patent in the United States expired in February 2015, the competition for the product may be delayed after Sanofi filed a patent infringement lawsuit against Lilly at the beginning of the year In this case, ly2963016 infringed four patents of Sanofi, while Lilly believed that ly2963016 was not a biological generic drug Original address: http:// TSID = 28 & region? Id = 3 × axzz362lf8zlo