FDA kind of OKs Lilly/BI's Lantus look-alike

Share this article:
EMA advisory panel backs Lilly's empagliflozin
FDA kind of OKs Lilly/BI's Lantus look-alike

The FDA's tentative approval of the Eli-Lilly and Boehringer Ingeleim diabetes medication Basaglar (insulin glargine) means that Sanofi's Lantus (also insulin glargine) is going to have to make room on pharmacy shelves. In just less than 30 months.

Sanofi's patent-infringement lawsuit prevents the FDA from granting Lilly and BI a full approval until the hold expires, or if the court sides with Lilly before then.

The drug is technically a Lantus biosimilar and is known in Europe 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 by convincing them that the Lilly-BI iteration deserves to bump Lantus off prescription lists. An added challenge: the Lantus patent is scheduled to expire 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 insulin glargine were not “substantially different from Lantus.”

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...