CHMP backs Lilly's insulin glargine

EMA's CHMP recommended marketing authorization of Abasria insulin glargine ( LY2963016) from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and II diabetes. Lilly said the basal insulin glargine analog has the same amino acid sequence as Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) and therefore was filed through EMA's biosimilar pathway. CHMP said the product is the first biosimilar insulin to be recommended for approval in the EU. A final decision from the European Commission is expected in about two months.

Abasria is also under review in the U.S. and Japan to treat Type I and II diabetes. Lilly and Boehringer said the product is considered a biosimilar in some regions, including the EU, but not in others, including the U.S. The product was submitted in the U.S. 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. The PDUFA date is not disclosed. ...