Endocrinology and Metabolic Disorders

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally. On 27 June 2014, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) had recommended granting of marketing authorization for a biosimilar insulin glargine product (LY2963016). Eli Lilly and its partner Boehringer Ingelheim has produced the biosimilar insulin glargine, which will be called as Abasria (LY2963016). The drug is a biosimilar of French drugmaker Sanofi’s diabetes drug Lantus (insulin glar...