Langlara, third interchangeable biosimilar to Lantus, approved by FDA

The FDA has approved a third biosimilar to Lantus (insulin glargine), a synthetic, long-acting version of human insulin.

Langlara (insulin glargine-addy) joins Semglee (insulin glargine-yfgn), approved by the FDA, and Rezvoglar (insulin glargine-aglr) on the market as biosimilars to Lantus, which has maintained market shae a mainstay of treatment of Type 1 and Type 2 diabetes that maintains and improves insulin levels.

Lanexa Biologics LLC, a wholly owned subsidiary of Lannett Company, is partnering with Sunshine Lake Pharma, a Chinese pharmaceutical manufacturer and research company, to manufacture, distribute and commercialize Langlara.

“Often, the greatest barrier to care for patients living with diabetes is the cost or the availability of the medicine itself. 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,” Tim Crew, CEO of Lannett, said in a news release about the approval.

The FDA has designed Langlara as interchangeable to Lantus, which means that, depending on state pharmacy levels, pharmacists can substitute it for Lantus without circling back to the prescribing physician for approval. To speed up the approval process for biosimilars, the FDA has moved toward allowing biosimilar makers to submit pharmacokinetic and pharmacodynamic data to prove interchangeability rather than testing products in human studies.

Earning the interchangeability designation is “critical for patient access and reflects the extraordinary quality and scientific rigor of both Lannett and our partner Sunshine Lake Pharma,” Crew said in the news release.

Not all biosimilars have the interchangeable designation, but Semglee and Rezvoglar do.

According to the Center for Disease Control and Prevention’s National Diabetes Statistics Report, issued in March 2026, 40.1 million people in the U.S. are living with diabetes, 2.1 million of whom have Type 1 diabetes. According to the report, 11 million of the 39.8 million adults living with diabetes haven’t been diagnosed. The CDC report says that 3.8 million of the adults with diabetes, or approximately 13.3% of those with diabetes, start using insulin within a year of getting diagnosed.

Insulin products vary in their strength and how quickly they reach the bloodstream. There are, for example, rapid-acting formulations that begin to work approximately 15 minutes after they are injected. By contrast, insulin glargine takes several hours to reach the bloodstream, but it is also longer lasting and maintains and lowers blood glucose levels for approximately 24 hours.

Biosimilars were supposed to bring price competition to biologics in the same way generic medications have done for small-molecule drugs such as statins. Their track record has been mixed since the FDA approved the first biosimilar in 2015, with some of the manufacturers of some brand-name “reference” products ceding market share to the biosimilar manufacturers while others have kept the competition at bay by cutting prices and by other means. Insulin prices became a political issue several years ago, and the Inflation Reduction Act of 2022 mandated a $35 cap for out-of-pocket costs for a 30-day supply for Medicare Part D beneficiaries starting in 2023. Sanofi, the maker of Lantus, announced in March 2023 that it was cutting the list price of its widely prescribed insulin produced by 78%.

Research findings presented at the annual meeting of ISPOR, the professional society for health economics and outcomes research, held earlier this month in Philadelphia, suggest Sanofi is among reference product makers that have maneuvered to maintain the dominance of their brand-name drug. Ting-Ying Jane Huang, Ph.D., director of research consulting at Komodo Health, a healthcare data analytics company, and her colleague, Jingjing Qian, Ph.D., of Auburn University, used a Komodo database to assess the insulin glargine market. They found the monthly proportion of Semglee claims increased from 0% in July 2021, the month it was approved, to 13.6% in October 2025. The trend in the monthly proportion of patients who filled Semglee prescriptions was nearly identical from 0% in July 2021 to 13.7% in October 2025. Their findings suggest that Eli Lilly has had difficulty making a dent with Rezvoglar. In October 2025, it accounted for only 0.8% of insulin glargine claims and patients.

“Mild uptake of insulin glargine biosimilars in the insured populations was observed within the first 4 years of marketing in the U.S.,” concluded Huang and Qian, adding that “further exploration” of the factors that might explain the situation is warranted.