ARTICLE | Regulation
Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.
FDA decision is a blow for Sanofi, which markets blockbuster Lantus
June 12, 2020 2:09 AM UTC
After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes.
Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan N.V. (NASDAQ:MYL) cleared the last IP hurdle for their product in March when the U.S. District Court of New Jersey invalidated claims for U.S. Patent 9,526,844 held by Sanofi (Euronext:SAN; NASDAQ:SNY) covering Lantus insulin glargine (see “Biocon, Mylan Look Ahead to U.S. Launch of Insulin Glargine”)...