FDA Approves Lillys Insulin Glargine Biosimilar, Rezvoglar

The US Food and Drug Administration (FDA) has approved Eli Lilly’s biosimilar version of insulin glargine, Rezvoglar KwikPen.

The new formulation is the second long-acting glargine “biosimilar,” a designation established by the FDA in March 2020 to regulate insulin and other biologics separately from drugs. The first one, Semglee (Mylan Pharmaceuticals) was approved as a glargine “follow-on” and was given the “biosimilar” designation in June 2020.

This also made it “interchangeable” for Lantus (Sanofi) so that it could be substituted at a pharmacy without the need for a separate prescription.

Although it is a glargine “biosimilar,” Rezvoglar is not approved for interchangeability with Lantus because Semglee has 1-year exclusivity from first commercial marketing before another interchangeable biosimilar to Lantus may be approved, Lilly spokesperson Kristiane Bello told Medscape Medical News.

Another glargine copycat, Basaglar (Eli Lilly) was approved in December 2015 as the first insulin “follow-on.” It, too, is not interchangeable with Lantus.

Several lower-cost short-acting insulin analogues have been approved thus far, including Sanofi’s lispro follow-on Admelog, Lilly’s “authorized generic” Lispro, and Walmart’s ReliOn Novolog (insulin aspart). The brand-name version of lispro is Humalog (Lilly) and of aspart is Novolog (Novo Nordisk). No short-acting biosimilar has been approved yet.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.

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