FDA Approves Sanofi's Langlara as Lantus Biosimilar

The FDA approved insulin glargine-aldy (Langlara) on April 29 as an interchangeable biosimilar for Lantus. The same day, the agency granted priority review to Gilead's once-daily HIV treatment combining bictegravir and lenacapavir, and BeOne's TEVIMBRA for HER2+ gastric/esophageal adenocarcinoma as first-line therapy. Eli Lilly's oral GLP-1 Foundayo, approved in early April, launches at $149/month for uninsured patients and $25 for insured patients, competing with Novo Nordisk's Wegovy tablet (600K prescriptions in March).