The US Food and Drug Administration (FDA) gave final approval yesterday to a copycat version of insulin glargine injection (Basaglar, Eli Lilly and Company) for diabetes that is called a follow-on product by the agency and is a biosimilar in other parts of the world.
The long-lasting human insulin analogue is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Eli Lilly won approval for its new diabetes drug by demonstrating that it was similar enough to another insulin glargine injection on the market (Lantus, sanofi-aventis) to justify trust in its effectiveness and safety, according to an FDA news release. The manufacturer also submitted data specific to Basaglar, including data from two clinical trials, to further establish its clinical credentials.
Basaglar is administered subcutaneously with the manufacturer's KwikPen injector once daily at any time of day as long it is the same time every day. Clinicians should dose the insulin analogue on the basis of individual patients' needs. Patients should not use it during episodes of hypoglycemia. It is not intended for patients with hypersensitivity to insulin glargine or one of its ingredients.
Hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain were the most common adverse reactions linked to Basaglar in the clinical trials. The agency noted that any insulin comes with the risk for anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock.
EU Regulators Approved the Drug Last Year
Basaglar received tentative approval from the FDA in August 2014, but the agency put a 30-month hold on its market entrance because of a patent-infringement dispute with sanofi-aventis. The two manufacturers reached a settlement in September that allowed Eli Lilly to sell its product in the United States and elsewhere.
European Union regulators approved Eli Lilly's glargine insulin injection under the brand name Abasria, which was later changed to Abasaglar. In Europe, the product is considered a biosimilar, but the FDA does not call it that. The agency reserves that term for biological products licensed under a particular provision of the Public Health Service Act (PHSA) that are dead ringers for "reference" products already approved under that law. Basaglar was not approved as a biosimilar because there are no insulin glargines currently licensed under the PHSA. Lantus, its reference product, was approved under a different law, the Federal Food, Drug, and Cosmetic Act, an FDA spokesperson told Medscape Medical News.
Instead, the FDA calls Basaglar an example of a follow-on product.
More information on the FDA's decision is available on the agency's website.
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Cite this: Insulin Glargine Copycat (Basaglar) Okayed by FDA - Medscape - Dec 17, 2015.