A big moment has arrived for Americans with diabetes, as a new insulin manufacturer has entered the market with a dramatically lower-priced insulin that could shake up the competition to help lower prices overall.

Say hello to Semglee, a new prescription basal (long-acting) insulin made by Pharma companies Mylan and Biocon. Launched in the United States on Aug. 31, this drug is a knockoff of Sanofi’s popular long-acting Lantus insulin.

But it will cost nearly 3 times less than the list price of Sanofi’s Lantus, which in 2019 clocked in at $283.56 for a single vial and $425.31 for a box of five pens.

  • Semglee has been available under different product names in Europe and 45 other countries for at least a couple years, prior to the Food and Drug Administration (FDA) clearance for the U.S.
  • It received FDA clearance in June 2020.
  • It’s FDA-approved for adults with both type 1 and type 2 diabetes, and children with diabetes ages 6 to 15.
  • It comes in U-100 concentration in the traditional 10-mL glass vial, as well as 300-unit, prefilled insulin pens with one-unit dosing increments (as displayed on the pen’s white plunger that extends during dosing).
  • You may see the term “insulin glargine” attached to the product. That’s just the official scientific lingo for this long-acting form of insulin that goes by different brand names depending on who makes it.
  • Semglee carries the exact same indications and amino acid sequence as Lantus, so for all practical purposes it is a lower-cost version of the same drug.
  • Technically, Semglee is not a “generic” but is officially considered a “follow-on” insulin, which basically means it’s a copy of an already-approved product.
  • This is the second copycat of Lantus; the first was Eli Lilly’s Basaglar in late 2015.

You can find more information on the newly launched website Semglee.com.

What’s most exciting about this new insulin is the effect it may have on the market as a whole. The ‘big three’ insulin manufacturers Eli Lilly, Novo Nordisk, and Sanofi have dominated the market for injectable insulins for decades. More recently, MannKind’s Afrezza inhaled insulin is making a small dent as well. Many are speculating about how a fifth insulin manufacturer like Mylan entering the American market may shake up competition in a way we haven’t seen before.

And by that, we mean the effect on insulin pricing.

The manufacturers confirm that Semglee is listed at $98.65 per 10mL vial and $147.98 for a box of five pens. That comes out to 3 times less expensive than the list price of Sanofi’s Lantus.

That pricing is also about half the cost of Lilly’s Basaglar, which was the first Lantus copycat to be approved in late 2015.

Mylan says it priced Semglee at the level where Lantus pens started in 2007, and where those insulin vials were priced in 2010.

It’s worth noting that the main company behind Semglee, Mylan, is most commonly known for making the EpiPen, whose high prices prompted public outcry back in 2016. The company eventually caved and lowered the price for this allergy emergency rescue pen. It’s possible that as Mylan now enters the insulin market, that past negative PR storm serves as inspiration to concentrate on low list prices.

Our Diabetes Community has been protesting skyrocketing insulin prices for many years now, with the #insulin4all movement gaining major steam. Some policy changes are happening at the state level, but big insulin makers have made only incremental “Band-Aid-type” improvements in offering narrow financial assistance programs. These programs are quite often not accessible to many people who need them most.

Pharma companies have stated they can’t just lower their list prices, because that interferes with contracts and would make the insulin unaffordable to many who currently access it through their insurance plans and pharmacy benefits.

The fact is that list prices remain obscenely high for most insulins and this new Semglee is now breaking that streak. For the first time in over a decade (since the late 2000s), the United States has an insulin at a list price lower than $100.

Some believe Semglee’s price is still too high, in light of a 2018 study published in the BMJ Global Health journal that estimates the actual cost of insulin production.

Even at its lower price, Semglee’s manufacturers will follow the lead of other insulin makers offering financial assistance and discount programs to help those in need.

“While providing our product at the most competitive list price on the market is an important step toward ensuring that those who need insulin are able to access and afford it, we also know that there is still work to be done to ensure this access and affordability reaches patients at the pharmacy counter,” Mylan CEO Heather Bresch said in a statement. “We remain committed to work across the healthcare system to improve outcomes for all.”

Of course, patient advocates must remain diligent and push for Mylan to not continue raising prices — especially as insurers and Pharmacy Benefit Managers (PBMs) negotiate backdoor rebates that Pharma claims to be the big reason their initial list prices go up. This is what happens with the existing big-name injectable insulins, in a sort of “pay to play” system where higher rebates incentivize insurers to provide better access to specific medications.

There’s no guarantee that pricing won’t change, but here’s hoping this new player can help break that cycle.