BioCentury
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Tentative FDA approval for Lilly, Boehringer insulin glargine

August 20, 2014 1:47 AM UTC

FDA granted tentative approval to Basaglar insulin glargine ( LY2963016) from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and Type II diabetes. The tentative approval is based in part on data from two open-label Phase III trials showing once-daily Basaglar -- a basal insulin analog -- met the primary endpoint of non-inferiority to once-daily Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) in reducing HbA1c from baseline to week 24 (see BioCentury Extra, June 16).

The application was reviewed under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. According to Lilly, Basaglar has the same amino acid sequence as Lantus.In the EU, the compound is being evaluated through EMA's biosimilar pathway. In June, EMA's CHMP backed approval of Basaglar under the name Abasria (see BioCentury Extra, June 27). ...