EC approves Lantus biosimilar

The European Commission approved Abasria insulin glargine from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and II diabetes. The basal insulin glargine analog was approved as a biosimilar of Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). Sanofi reported EUR 5.7 billion ($7.8 billion) in worldwide sales of Lantus in 2013. Abasria is the first biosimilar insulin to be approved in the EU.

Last month, FDA granted tentative approval to the product as Basaglar. Lilly and Boehringer did not submit Basaglar under the U.S. biosimilars pathway. As a result of ongoing patent litigation in the U.S., full FDA approval could be delayed until mid-2016 (see BioCentury Extra, Aug. 19). ...