Indianapolis-based Eli Lilly and Co. plans to introduce its version of Sanofi’s Lantus insulin for diabetes in Europe in the third quarter, said Enrique Conterno, the president of Lilly Diabetes.
The patent on Lantus expired in May, according to Lilly, opening the door for its “biosimilar,” a copycat version of Sanofi’s blockbuster drug.
“We expect there’s going to be an adoption curve of these therapies,” Conterno said in a telephone interview. “When it comes to insulin, this is unprecedented. We have to see how this plays out in Europe and the U.S.”
Conterno declined to comment on how the Lilly biosimilar will be priced. Drugmakers have been grappling with the introduction of copycat drugs in the biologic field, which are likely to push down the prices of lucrative products. Biosimilars are imitations of biologic drugs that are based on living organisms, as opposed to generic drugs that are copies of relatively more straightforward chemical-based drugs.
Lantus is Sanofi’s best-selling product. Last year, the company reported $7.05 billion in sales from the drug, up 12 percent from the previous year.
The U.S. Food and Drug Administration has granted tentative approval for Lilly’s competitor to Lantus, which will be called Abasaglar in Europe and is being developed with Boehringer Ingelheim GmbH. The biosimilar will be called Basaglar when marketed in the U.S.
The drug meets the regulatory requirements for approval, though it’s subject to a delay because of patent-infringement litigation filed by Sanofi. That prevents the agency from giving final approval until mid-2016, unless the court finds in favor of Lilly earlier, the company has said previously.
Conterno said Lilly remains committed to developing another drug, basal insulin peglispro, even with signs that it raises liver enzymes in patients.
The company is still investigating why exactly that happens, David Kendall, vice president of medical affairs for Lilly Diabetes, said in an interview. The drug has other benefits, he said, adding it demonstrated better blood sugar control and less weight gain in patients with adult-onset Type 2 diabetes when compared with those taking Lantus.
“No other insulin has shown to be more effective,” Conterno said of the company’s product. Lilly said in February that it would delay its regulatory submission beyond the first quarter of this year to generate more data about the changes in liver fat observed with the drug.
“We want to take this to a conclusion,” Conterno said of the investigations of the drug. “This program for us is truly critical.”