Abasria insulin glargine regulatory update

The European Commission approved Abasria insulin glargine from Eli Lilly and Boehringer 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, Paris, France). Sanofi reported EUR5.7 billion ($7.8 billion) in worldwide sales of Lantus in 2013. Abasria is the first biosimilar insulin to be approved in the EU. In 2011, Lilly and Boehringer partnered to co-develop and co-commercialize a portfolio of diabetes candidates, including Abasria (see BioCentury, Jan. 17, 2011).

Last month, FDA granted tentative approval to the product as Basaglar. The partners 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, Sept. 1). ...