HGS believes in-house manufacturing capacity may be insufficient within a few years post-launch.
Human Genome Sciences named Lonza as its commercial-scale manufacturing partner for the systemic lupus erythematosus (SLE) therapy Benlysta®. Currently under regulatory review in the U.S. and Europe, the drug has been developed by HGS in collaboration with GlaxoSmithKline (GSK). HGS says that it selected Lonza for commercial manufacture of Benlysta after reviewing proposals from a number of CMOs.
“Our HGS large-scale manufaturing facility has ample capacity to provide worldwide supply of Benlysta following approval and for the first two or three years following launch,” comments Randy J. Maddux, HGS’ vp of manufacturing operations. “However, we believe that we will eventually require additional capacity.”
HGS points out there has been no new drug approved for the treatment of SLE for over 50 years. In June the firm filed its BLA for Benlysta with FDA, and GSK submitted its MAA for the drug to European regulatory authorities.