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FDA Approves Interchangeable Insulin Glargine Biosimilar Langlara™ (insulin glargine-aldy)

by Leah Watson; Robert S. Schwartz, Ph.D.
May 7, 2026

On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara™ (insulin glargine-aldy) biosimilar to Sanofi’s Lantus® (insulin glargine), for the treatment of adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.

The FDA granted Langlara™ an interchangeable designation, permitting substitution for Lantus® at the pharmacy level without prescriber intervention, subject to applicable state laws.

The approval was supported by analytical, preclinical, and clinical data demonstrating that Langlara™ has comparable pharmacokinetic and pharmacodynamic profiles, efficacy, safety, and immunogenicity to Lantus®.

Langlara™ becomes the third insulin glargine biosimilar available in the U.S. and the first from a Chinese company.

Sanofi reported U.S. sales of approximately $952M for Lantus® in 2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

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The authors would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable 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 BiologicsHQ database.

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