US regulators have agreed to review Eli Lilly/Boehringer Ingelheim’s long-acting insulin LY2963016, a biosimilar of Sanofi’s blockbuster diabetes treatment Lantus (insulin glargine). The US Food and Drug Administration will assess the drug as a treatment for both type I and type II diabetes, following in the footsteps of regulators across the pond in Europe. Lilly and Boehringer say they have studied LY2963016 “in a comprehensive development programme in order to meet the regulatory standards of clinical and nonclinical safety, efficacy and quality,” and note that the filing also contains data from Phase III trials in which their treatment was pitted against Lantus.
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