Admelog, a short-acting insulin lispro injection, is a follow-on product approved through an abbreviated pathway under the FDA’s Federal Food, Drug, and Cosmetic Act. FDA Commissioner Scott Gottlieb is delivering on his promise to encourage more competition in the marketplace, cheering the approval in today’s statement.
“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” Gottlieb said. “This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease. In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”
Last year, Eli Lilly’s top selling product was Humalog, bringing in $2.76 billion in global sales. The drug is no longer protected by patents, but Lilly could win an extra 2.5 years of market exclusivity if it chooses to sue for infringement on its patent-protected KwikPen injection device, analysts have noted.
The increased competition is the latest bad news for Lilly. The drugmaker has had a tough time realizing price increases due to payer playing hardball — pitting rival diabetes companies against each other to negotiate lower prices. This September, the company slashed R&D jobs, shuttered two research sites and announced plans to cut 3,500 staffers in hopes of saving $500 million in annual expenses.
Sanofi’s new approval for Admelog doesn’t come as a big surprise, as the company was granted tentative approval from the FDA in September.
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