On June 27, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced granting of preliminary marketing approval for the European Union’s first biosimilar insulin glargine product.
Called Abasria (LY2963016), the investigational basal (long-acting) insulin is intended for the treatment of type 1 and type 2 diabetes. Abasria, like its reference product, the diabetes drug Lantus (insulin glargine), produced by Sanofi-Aventis, binds to the human insulin receptor and results in the same pharmacological effects as human insulin.
Abasria is produced by Eli Lilly in partnership with Boehringer Ingelheim.
The CHMP’s recommendation follows its manufacturers’ announcement in June that (LY2963016) has demonstrated a similar safety and efficacy profile to Lantus. The results of these studies, first announced at the 74th American Diabetes Association Scientific Sessions held in San Francisco, were specifically cited in the CHMP opinion.
The CHMP’s recommendation for Abasria will now be referred to the European Commission which grants approval for the European Union, Norway and Iceland. The Commission’s final approval is anticipated by September 2014.