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On July 28, 2021, the FDA approved Viatris (formerly Mylan) and Biocon Biologics’ Semglee® (insulin glargine-yfgn) as the first interchangeable biosimilar in the U.S. Semglee is both biosimilar to, and interchangeable with Sanofi’s Lantus® (insulin glargine).  Based on its prescribing information, Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

According to the FDA, “The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and interchangeable with Lantus (insulin glargine), is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) in terms of safety, purity and potency (safety and effectiveness). It also showed that Semglee (insulin glargine-yfgn) can be expected to produce the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) is not greater than the risk of using Lantus (insulin glargine) without such switching.”

Since Semglee was approved as an interchangeable, it can be automatically substituted for Lantus at the pharmacy without intervention from the prescribing physician (similar to how generic drugs are substituted for brand name pharmaceuticals), subject to each state’s pharmacy substitution laws. Semglee was initially launched in the U.S. in August 2020 and is available in 10 mL vials and 3 mL prefilled pens.  Biocon stated that it will transition the current product to the interchangeable product over the next few months.

According to Biocon, because Semglee is the first approved interchangeable biosimilar to Lantus, Semglee is eligible for 12 months of product exclusivity (from the date of commercial launch) before the next interchangeable biosimilar referencing Lantus can be approved.

The FDA press release can be viewed here.
The Biocon press release can be viewed here.


    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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