French drugmaker Sanofi won Food and Drug Administration approval last week to sell its newest long-acting diabetes medication Toujeo as the company looks to repeat the success of its blockbuster insulin product Lantus.
But experts say the drug's benefits may not prove significant enough to make it the kind of hit that would offset what the company stands to lose when patent protection for Lantus expires this year.
While physicians say Toujeo is a definite improvement upon Lantus, its introduction to the market does not mark the kind of groundbreaking innovation many saw Lantus as being when it first became available. That may prompt some providers to stick with Lantus if Toujeo is priced at a premium.
“I don't think it offers the same level of excitement” as Lantus, said Dr. Laura Butz, an endocrinology fellow at the University of Michigan Health System's internal medicine department in Ann Arbor, said of Toujeo. “It does have some benefits and I think in some patients it's definitely going to be beneficial, like those who tend to have lower blood sugar overnight—but it's not going to be quite the game-changer.”
That means the degree to which providers and patients jump to Toujeo will depend to a significant degree on how Sanofi prices the drug.
Seamus Fernandez, a research analyst who covers major and specialty pharmaceuticals for investment bank Leerink Partners, said he expects about a fifth of patients taking Lantus will switch to Toujeo and that Sanofi will price Toujeo the same or less than Lantus for payers but with a higher sticker price.
“The list price could be higher, but that's relatively meaningless,” Fernandez said. “It really comes down to what they negotiate the price and the discounts to be behind the scenes.”
Toujeo is a once-a-day insulin injection for adults living with either Type 1 or Type 2 diabetes. The treatment carries a higher concentration of the same active ingredient found in Lantus, called insulin glargine, and is designed to release insulin more gradually. A company statement released last June said Toujeo was found to consistently show “significantly fewer low blood sugar events” compared with Lantus.
That benefit was noted in the recommendations for the drug's approval issued last week by European regulators. In its “positive opinion” for the marketing of Toujeo, the European Medicines Agency's Committee for Medicinal Products for Human Use found incidence of hypoglycemia was lower with Toujeo among Type 2 diabetics, particularly at night, compared with patients taking Lantus.
But Sanofi will have to fend off growing competition from drugmakers developing biosimilar versions of Lantus.
Rivals such as Eli Lilly and Co. and Merck & Co. are attempting to develop cheaper versions of Lantus that could erode the market share held by the drug, which represents more than 15% of Sanofi's total sales.
“Biosimilars are going to take a portion of the market,” Fernandez said. “The big question is how they are going to price their drug.”
Experts say the introduction of biosimilar medications to the market could save billions in drug costs. But unlike generic drugs, where prices for original chemical medicines can be cut dramatically, some say the cost involved in the development, production and eventual marketing of a biosimilar makes it unlikely such medications will provide the same amount of savings.
A Sanofi representative said in an e-mailed statement that the company plans to make pricing information available at the time of Toujeo's U.S. launch, which is planned for the beginning of the second quarter of 2015.
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