The FDA’s tentative approval of the Eli-Lilly and BoehringerIngeleim diabetes medication Basaglar (insulin glargine) means that Sanofi’s Lantus (also insulin glargine) is going to have to make room on pharmacy shelves. Injust less than 30 months.
Sanofi’s patent-infringement lawsuit prevents the FDA fromgranting Lilly and BI a full approval until the hold expires, or if the courtsides with Lilly before then.
The drug is technically a Lantus biosimilar and is known inEurope as Abasria, but it is not considered a biosimilar in the US.
The almost-approval gives Lilly and BI a mixed challenge—generic Lantus gives the new entrant the credibility of being a new treatment,but being an insulin glargine, it also has to win over payers and patients byconvincing them that the Lilly-BI iteration deserves to bump Lantus offprescription lists. An added challenge: the Lantus patent is scheduled toexpire next year.
Lilly is clearly hopeful that the drug could best Lantus:CEO John Lechleiter said in January the drug would not launch if it’s insulinglargine were not “substantially different from Lantus.”