The US Food and Drug Administration has approved the first-ever generic glucagon injection kit for the treatment of severe hypoglycemia in patients with diabetes and as a diagnostic aid.
The FDA determined that Amphastar Pharmaceuticals' Glucagon for Injection Emergency Kit, 1 mg, a synthetic peptide product, is bioequivalent and therapeutically equivalent to Eli Lilly's recombinant DNA Glucagon Emergency Kit for Low Blood Sugar.
Both require a multistep mixing process that means they are complicated to use.
In 2019, FDA approved two branded, easier-to-use formulations of glucagon — one nasally administered (Baqsimi, Eli Lilly & Co) and the other a prefilled pen or syringe (Gvoke HypoPen and Gvoke PFS, respectively, Xeris Pharmaceuticals).
The new generic will have the advantage of lower cost, Amphastar spokesman Dan Dischner told Medscape Medical News in an email.
"Our generic glucagon will be priced as a generic product so that patients will benefit from a lower price. As we are just at the beginning of the commercialization of the product, we are unable to discuss our specific product price," he wrote.
As with the branded Lilly injectable glucagon, the new generic is also indicated as a diagnostic aid in gastrointestinal radiologic imaging, as glucagon slows gastric motility.
According to an FDA statement, glucagon is a "complex product" that has been difficult to manufacture generically despite the lifting of patent protection. This approval was the result of the FDA's efforts to encourage the development and submission of applications for such drugs.
Amphastar specializes in "developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products," the company website says.
Dischner said, "Glucagon is a complex product that requires R&D and manufacturing capabilities to develop a highly purified synthetic peptide product bioequivalent and therapeutically equivalent to the recombinant DNA origin Glucagon. Given that this product has been through various review cycles, its complexity, and the technological capabilities required to manufacture, it is no surprise that there hasn't been a generic of glucagon until now."
Side effects of injected glucagon include nausea, vomiting, transient increase in heart rate, and redness/swelling of the injection site.
Dischner added, "We are confident that our generic to Lilly's time-tested glucagon will provide a favorable option, at a reasonable price, to patients who rely on this product."
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Cite this: FDA OKs First Generic Injected Glucagon for Hypoglycemia - Medscape - Dec 30, 2020.