FDA Approves Langlara, Third Lantus Biosimilar

TL/DR –

The FDA has authorized a third biosimilar to Lantus, a synthetic, long-acting form of human insulin, called Langlara (insulin glargine-addy). The FDA deemed Langlara as interchangeable to Lantus, which means pharmacists can replace it with Lantus without requiring approval from the prescribing doctor. The biosimilar will be manufactured, distributed, and commercialized by Lanexa Biologics, a subsidiary of Lannett Company, in collaboration with Sunshine Lake Pharma.

FDA Approves Third Biosimilar to Lantus, Langlara

The U.S. Food and Drug Administration (FDA) has given the green light to Langlara (insulin glargine-addy), marking it as the third biosimilar approved for Lantus (insulin glargine), a synthetic and long-acting version of human insulin. Langlara joins Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr), which are both already in the market as biosimilars to Lantus. This insulin brand has established its presence as a primary treatment for Types 1 and 2 diabetes by regulating and improving insulin levels.

Production and Commercialization Partnership

Lanexa Biologics LLC, a fully-owned subsidiary of Lannett Company, is partnering with Sunshine Lake Pharma, a pharmaceutical manufacturer and research company based in China. These two firms will work hand in hand in the manufacturing, distribution, and commercialization of Langlara. Both companies aim to provide a safe, affordable, and accessible treatment option to patients living with diabetes.

According to Lannett CEO Tim Crew, the greatest obstacle to diabetes care is often the cost or availability of medication. He stated, “Upon the launch of Langlara, supported by the tremendous manufacturing scale of our partner, patients will have expanded access to a safe, affordable and available treatment option.”

Langlara as an Interchangeable to Lantus

Langlara has earned the FDA’s interchangeable designation to Lantus. This allows pharmacists, depending on the state pharmacy levels, to substitute Langlara for Lantus without needing to get approval from the prescribing physician. To expedite the approval process for biosimilars, the FDA has allowed biosimilar manufacturers to provide pharmacokinetic and pharmacodynamic data to establish interchangeability instead of conducting studies on human subjects.

Not all biosimilars receive the interchangeable designation, but Semglee and Rezvoglar do. This interchangeability designation, according to Tim Crew, is “critical for patient access and reflects the extraordinary quality and scientific rigor of both Lannett and our partner Sunshine Lake Pharma.”

Diabetes Prevalence in the U.S.

According to the National Diabetes Statistics Report by the Center for Disease Control and Prevention (CDC), published in March 2026, around 40.1 million people in the United States are living with diabetes. Among these, 2.1 million have Type 1 diabetes. The report also suggests that out of the 39.8 million adults with diabetes, around 11 million are yet to be diagnosed. Approximately 13.3 percent or 3.8 million adults with diabetes start insulin use within a year of diagnosis.

Role of Biosimilars in Price Competition

Biosimilars were intended to introduce price competition among biologics, similar to the role generic medications play for small-molecule drugs like statins. However, their performance has been inconsistent since the first FDA biosimilar approval in 2015. Some manufacturers of brand-name “reference” products have yielded market share to biosimilar manufacturers, while others have maintained their hold by reducing prices and other methods.

A notable example is Lantus’ maker, Sanofi, which reduced the list price of its widely prescribed insulin by 78% in March 2023. This came in response to the Inflation Reduction Act of 2022, which capped the out-of-pocket cost for a 30-day insulin supply for Medicare Part D beneficiaries at $35, beginning in 2023.

Research Findings on Biosimilar Uptake

A research presentation at the recent ISPOR annual meeting, a renowned professional society for health economics and outcomes research, indicated that Sanofi and other reference product manufacturers have successfully maintained the dominance of their brand-name drug. The research led by Ting-Ying Jane Huang, Ph.D., Director of Research Consulting at Komodo Health, a healthcare data analytics firm, revealed that the monthly proportion of Semglee claims increased from 0% in its approval month (July 2021) to 13.6% in October 2025. The study also found that Eli Lilly had a minimal impact with Rezvoglar, which only constituted 0.8% of insulin glargine claims and patients in October 2025.

These results suggest a “mild uptake” of insulin glargine biosimilars in insured populations within the first four years of U.S marketing, requiring further exploration of contributing factors, according to Huang and her colleague, Jingjing Qian, Ph.D., of Auburn University.

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