Merck and Samsung Bioepis will collaborate on clinical development, regulatory filings and manufacturing. If approved, Merck will be responsible for commercialization. The initial collaboration established in February 2013 was to develop and commercialize multiple biosimilar candidates. Insulin glargine is currently marketed by Sanofi as Lantus. Lilly and Boehringer Ingelheim recently filed a biosimilar of insulin glargine for review with FDA, but Sanofi filed a patent infringement suit against the companies at the end of January, which could trigger a 30-month delay at the FDA.
“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” said Matt Strasburger, senior vice president, Diabetes, Global Human Health, Merck. “Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of the disease.”
“Samsung Bioepis is very pleased to extend the partnership with Merck to the field of diabetes,” said Christopher Hansung Ko, Ph.D., chief executive officer of Samsung Bioepis. “This collaboration will bring better access to patients with diabetes worldwide.”