The US Food and Drug Administration (FDA) has approved Admelog (Sanofi-Adventis US), the first copycat version of short-acting insulin lispro (Humalog, Eli Lilly) to treat individuals aged 3 years and older with type 1 diabetes and adults with type 2 diabetes.
The product is approved for use as an injection, via pump, or intravenously. It will be available both in vials and as a prefilled pen (Admelog SoloStar).
The FDA approved Admelog through an abbreviated approval pathway under which companies can rely on the FDA's previous approval of a drug as safe and effective or on previously published literature supporting safety and/or effectiveness. This process is meant to reduce drug development costs in order to reduce the drug's price on the market.
"One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. 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," FDA Commissioner Scott Gottlieb, MD said in a statement.
Products approved through this particular pathway are technically called "follow-ons" in the United States and "biosimilars" in other parts of the world. The FDA previously approved another follow-on insulin, the long-acting Basaglar (Eli Lilly's version of insulin glargine), in December 2015.
For Admelog, Sanofi-Aventis's application relied on the FDA's previous findings of safety and effectiveness for insulin lispro to support approval. The company also submitted additional data for Admelog from two phase 3 clinical trials of approximately 500 patients each.
The most common adverse reactions associated with Admelog were hypoglycemia, itching, and rash. The product may also cause allergic reactions, injection site reactions, and lipodystrophy.
Cautions regarding Admelog are similar to those of all insulin products, including hypoglycemia risk; not sharing needles; close monitoring with changes in insulin dosing, with coadministration of other glucose-lowering products, and in patients with renal or hepatic impairment or hypoglycemia unawareness.
Providers are also advised to monitor potassium levels in patients at risk for hyperkalemia. The label also cautions about increased risk for heart failure when the drug is used together with thiazolidinediones.
The FDA granted Admelog provisional approval in September 2017, and this is now the final approval. The product was licensed in the European Union in July 2017 under the name Insulin Lispro Sanofi
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Cite this: First Humalog Copycat (Admelog) Approved by FDA - Medscape - Dec 11, 2017.