FDA clears first generic glucagon for injection kit

The Food and Drug Administration as approved the first generic of a drug used to treat severe hypoglycemia. The agency has approved a generic glucagon for injection, 1 mg, from Amphastar Pharmaceuticals. The generic is a synthetic peptide product that the FDA has deemed to be bioequivalent and thus therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar. 

"Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar," said Sally Choe, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research. "Today's approval reflects the FDA's continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts. Supporting development and expanding opportunities to bring generic copies of complex drugs, like glucagon, to the market has been a major focus of our efforts to improve competition and help lower drug prices."

The FDA said that glucagon for injection is included on its list of off-patent, off-exclusivity drug products that don’t have an approved generic, which the agency keeps to encourage development and submission of applications for drugs with limited competition. The agency also prioritizes the review of the drugs on the list that have fewer than three approved generics with no blocking patents or exclusivities. 

“This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon,” said Amphastar CEO and president Dr. Jack Zhang. “This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.”

According to IQVIA, the U.S. sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million, and the overall U.S. sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020.

Amphastar said it plans to launch the product within two months.