FDA Approves Yet Another Glargine Insulin Biosimilar from Lannett Company/HEC

Today, there was a press release (see https://www.businesswire.com/news/home/20260504761789/en/Lannett-Company-Lanexa-Biologics-and-Sunshine-Lake-Pharma-announce-FDA-Approval-of-LANGLARA-an-Interchangeable-Biosimilar-of-Lantus-insulin-glargine for more) that another glargine insulin biosimilar had received FDA approval and will be coming to market soon. In this case, it will be branded as LANGLARA™ (insulin glargine-aldy) as a biosimilar to Sanofi's Lantus® (insulin glargine), for the treatment of adults and pediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. The FDA has also determined that LANGLARA is "interchangeable" with the reference drug, enabling pharmacists to substitute LANGLARA for Lantus without prescriber intervention in states that permit such substitution.

Depending on if you count different NDC numbers of the same molecule as genuinely separate products or not, with this copy of the basal insulin Lantus, there are now nine (9) different glargine products for sale in the U.S. market, including several sold at prices which are capped with a MaxRP (Maximum Retail Price). Among them are the following: 

• Sanofi Lantus (insulin glargine injection, 100 units/mL) 
• Winthrop by Sanofi Insulin Glargine [unbranded product] (insulin glargine injection, 100 units/mL) 
• Sanofi Toujeo (insulin glargine injection, 300 units/mL) very high-concentration insulin
• Lilly Basaglar (insulin glargine injection, 100 units/mL) approved as a follow-on biologic product
• Lilly Rezvolgar (insulin glargine-aglr injection, 100 units/mL) approved as an interchangeable biosimilar product 
• Biocon Biologics Semglee (insulin glargine-yfgn injection, 100 units/mL) approved as an interchangeable biosimilar product 
• CivicaScript Insulin Glargine (insulin glargine-yfgn injection, 100 units/mL)
• CalRx Insulin Glargine (insulin glargine-yfgn injection, 100 units/mL) 
• Lannett Company/HEC (insulin glargine-aldy injection, 100 units/mL) 

Now, I cannot really say whether all of these products still remain on the market at this time (for example, whether the "unbanded" version of Lantus from Sanofi's Winthrop business remains for sale or whether it has since been discontinued; I have not heard whether it's been discontinued or not), and we know that Civica's/CalRx's glargine products are being sold as part of a broader distribution plan, even while these products are technically the exact same biosimilar products sold by different entities. Biocon Biologics refers to this as "white labeling" its insulin biosimilars. There is a similar concept which exists in the retail segment, whereby retailers sell products under their "house" brand also referred to as private label products. It's the same concept with pharma.

And, to some extent, while they are indicative of a seemingly robust market for biosimilar insulin products in the U.S. (I think), even while the number of Lantus copies grows ever-larger, we know definitively because the companies bringing more copies to market report these details in their SEC filings are now pending FDA decisions from Sandoz/Gan & Lee, Amphastar Pharmaceuticals/ANP as well as Meitheal/THDB.

According to 46brooklyn Research's "Brand Drug List Price Change Box Score" which is accessible at https://www.46brooklyn.com/branddrug-boxscore, between 2024 and 2026, the list price for Sanofi's brand-name Lantus indeed fell by a stunning 78% (the price reductions applied to both the 10 mL vial format, and also for the SoloStar pen devices which cost more money on a per-unit basis) in 2024. Meanwhile, prices for the slower-selling 300 units/mL version of Lantus which branded as Toujeo fell by a mere 5%. I suspect that biosimilars may target the Toujeo product with lower prices, although keep in mind that because each unit of Toujeo contains three times as much insulin as Lantus (making it equivalent of 3 vials of Lantus, or 15 SoloStar pens), patients who use Toujeo can nevertheless anticipate more modest price reductions on biosimilars because they are using significantly more insulin.

According to FDA 2019 FDA (CDER) analysis, which examined the correlation between the number of generic entrants and market price, the more generics on the market, the lower prices fall. The data confirms that while the first generic offers only a moderate discount, the entry of 6 or more rivals triggers a price collapse of 95% or more relative to the brand price. The FDA conducts this research to measure the impact of the Drug Competition Action Plan (DCAP). The agency used these findings to identify "saturated" markets and to justify prioritizing the review of generic applications for "uncontested" molecules where competition—and therefore patient savings—was or is currently lacking. There is an archived copy of the FDA Press Release (Internet Archive) found at https://www.fda.gov/news-events/fda-brief/fda-brief-new-analysis-highlights-link-between-generic-drug-competition-and-lower-drug-prices while the Full Economic Study (PDF) can be found at https://www.fda.gov/media/133509/download.

So that's where we are now with Lantus. Prices on that are going to stay low, although the innovator Sanofi appears to be holding on to its share with biosimilars from companies like Biocon Biologics fighting over the remainder. I also question the necessity for insulin pens, which adds an additional 40% to the price of the insulin, is truly necessary for a basal insulin which is only injected once daily. Pens were created in order to dose PRANDIAL insulin while the patient is outside a home environment. To that end, insulin pens have become a marketing crutch which basal insulin makers rely on to make their products more palatable to insulin-naive Type 2 patients. There is not a necessity for a pen, although if these patients are willing to spend 40% more money, then let them do so.

We also now have two FDA approved copies of insulin aspart (Novolog/Fiasp), with Sanofi's Merilog biosimilar approved last February, followed by Biocon Biologics' Kirsty approved last July, More copies of that are also now pending, many from the same companies.

The Lannett Company press release contained some additional information of note. First, Lannett newly established a subsidiary known as Lanexa Biologics LLC to sell the company's biosimilar products including the newly approved LANGLARA glargine product. 

Second, on July 31, 2025, India-based Aurobindo Pharma announced its intent to acquire Lannett Company, Inc. and upon close of the acquisition, Lanexa will become a stand-alone company. 

Finally, the press release also said this: Chinese partner HEC established a U.S. subsidiary known as Sunshine Lake Pharma, which Lannett says will also continue to collaborate on a short acting insulin aspart which is now in development. Lannett Company initiated a process to commercialize a glargine biosimilar in 2016, and Lannett later expanded its strategic relationship with HEC in 2021, adding a new co-development agreement for an insulin aspart biosimilar.

Currently, aside from the image in the press release, I do not have an NDC number (or numbers) for LANGLARA, and we don't know if it will be sold in 10 mL vial format, either. No one really knows with certainty whether all these copies of Lantus can survive, especially since the selling prices are poised to plummet with each new biosimilar copy hitting the market. Meanwhile, the market for alternative basal insulins also eligible for biosimilar copies such as Levemir are being ignored. But they may ignore the market at their own peril.