For the first time, the Food and Drug Administration (FDA) has allowed a cheaper knock-off of an expensive brand-name insulin to be substituted for the original.

This more affordable called Semglee, a copycat of Sanofi’s basal (background) insulin Lantus, was first approved by the FDA in 2020. But now, it becomes the first-ever to earn the “interchangeable” designation, meaning it’s fully approved to be substituted for Lantus at the pharmacy counter, without the pharmacist needing to first get permission from a prescribing doctor.

Semglee is made by Pharma companies Biocon and Viatris (formerly Mylan), and it’s the first injected insulin product to be made by someone other than the “Big Three” insulin makers: Eli Lilly, Novo Nordisk, and Sanofi.

Notably, Semglee is a lower-priced insulin option at nearly 3 times less than the list price of Sanofi’s Lantus, which clocks in at $283.56 for a single vial and $425.31 for a box of 5 pens (see more pricing details below).

While some question remains over whether Semglee will remain as low priced, this marks a big moment for Americans with diabetes. It represents the fourth insulin manufacturer in the U.S. market with a dramatically lower-priced insulin that can be switched out easily, just like any generic drug. Observers believe this could shake up competition and potentially help lower insulin prices overall.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce healthcare costs,” said Dr. Janet Woodcock, acting director of the FDA. “[This approval] ultimately empowers patients by helping to increase access to safe, effective and high quality medications at potentially lower cost.”

  • Semglee has been available under different product names in Europe and 45 other countries for several years, prior to FDA clearance.
  • It is now 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 10mL glass vial (with 1,000 units), as well as 3mL prefilled insulin pens with one-unit dosing increments (as displayed on the pen’s white plunger that extends during dosing).
  • Semglee received initial FDA clearance in June 2020 and was available starting on Aug. 31, 2020. But the new version that’s considered interchangeable with Lantus is a different product with new labeling, so the manufacturer says it will be re-launching this insulin by the end of 2021.
  • You may see the term “insulin glargine” and “insulin glargine-yfgn” attached to the product, which is the official scientific lingo for this long-acting form of insulin that goes by different product names depending on who makes it.
  • Semglee carries the same scientific 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.
  • In late July 2021, the FDA approved Semglee as an “interchangeable” insulin, marking the first time regulators have allowed this label for a biosimilar product such as insulin. It indicates that Semglee has no clinical difference between Lantus, so pharmacists (in states that allow it) can switch out the more expensive Lantus for Semglee without first asking the prescriber or insurance company.
  • This is the second copycat of Lantus; the first was Eli Lilly’s Basaglar, launched in 2016.

You can find more specific information on the product website Semglee.com.

Yes, for all practical purposes, Semglee is equivalent to Lantus.

Unlike generic drugs, which share the exact same chemical composition as their pricier brand-name counterparts, biosimilar products like Semglee are “highly similar” duplicates of the reference brand name product (Lantus, in this case).

That is what the latest announcement by the FDA is all about.

“The interchangeable biosimilar product can be expected to produce the same clinical result as the reference product,” said Dr. Peter Stein, an endocrinologist who serves as director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research.

In a press call, Stein explained Semglee may be substituted at the pharmacy without needing to get permission from a prescriber first, similar to how lower-cost generic drugs are often substituted.

The FDA officially defines a drug as interchangeable if it meets the following criteria:

  • The drug is biosimilar to the reference product.
  • It produces the same clinical result as the reference product in any given patient.
  • There is no greater safety or diminished efficacy risk from switching between the interchangeable drug and the reference product.

In making this recent announcement, the FDA also released a series of healthcare provider materials to better understand what biosimilars and interchangeability means to them. It also created a Consumer Update about interchangeables for both patients and caregivers.

Mylan says it will be launching a new “interchangable” version of Semglee by the end of 2021. At that time, they’ll work with pharmacists to transition their Semglee orders and patients to this latest version with updated labeling.

Although the FDA now allows for pharmacy substitutions, there are differing state pharmacy laws in place. According to healthcare services giant Cardinal Health, that tracks this information, all 50 states and Washington D.C. have enacted laws for biologic interchangeability. Only a handful of states do not directly allow for automatic pharmacy-level substitution, unless there is a note on the prescription that a substitution can be made. Meanwhile, a few other states have taken a more nuanced approach in only allowing those auto-substitutions if it results in a lower cost to the patient.

This interactive map has a breakdown of specific state laws on this issue throughout the United States.

Dr. Anne Peters of the University of Southern California (USC) Keck School of Medicine is pleased to hear about the interchangeability, and believes it can be a convenience for some who might otherwise struggle to afford high-priced insulin. However, she urges caution because switching insulin isn’t something everyone will be comfortable with — at least not without first talking to their prescribing doctor.

“There are patients, particularly those with type 1, who may feel there are differences between the brand name and the biosimilar and will not want this change, especially without a conversation with their doctor,” she said. “This new biosimilar could confuse some doctors; there will be a need for more education to stress that these two insulins are, in fact, the same.”

Peters also notes how despite Semglee and Lantus being clinically the same insulin, the actual insulin pens used to inject each liquid are slightly different. So, that may be a factor in deciding which of these insulins someone wants to use.

“I have long wished there was an interchangeability among insulin analogues, so it was easier for switching,” Peters said. “On the other hand, I have so many patients who get upset about switching, because they feel comfortable with what they are prescribed. This approval is good if it makes insulin less expensive and more accessible. I just want to make sure we do not limit patient choice.”

A glaring irony with this latest development is all the positive fanfare around the first time an insulin can be switched out, regardless of what the patient or prescribing doctor may want.

Advocates have long been pushing back against the longstanding practice of Non-Medical Switching, where an insurance company or those creating the insurance formularies decides to cover a different insulin (or other drug) and change it out without the consent of the patient or doctor.

For years, many people with diabetes have been suddenly forced to switch from one type of insulin to another, simply because the insurance companies have struck a better business deal.

At the Diabetes Patient Advocacy Coalition (DPAC), longtime diabetes advocate George Huntley who lives with T1D himself, said, “The interchangeable designation by the FDA means that it is truly a unit-for-unit identical reaction. From a non-medical switching standpoint, it’s essentially a generic equivalent unlike switching that occurs in other circumstances.

He hopes that this development can be used to reduce non-medical switching for medications that do not have the interchangeable designation.

“As advocates we should work to hold the interchangeable designation to the be the standard for switching a medication,” Huntley said. “The prescriber should prevail.”

One of the most important aspects of Semglee entering the market is the potential effect on insulin pricing overall.

When it was first launched in August 2020, Semglee had the following pricing:

  • $98.65 per 10-mL vial
  • $147.98 for a box of five pens

That equates to three times less expensive than the list price of Sanofi’s Lantus, and 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 told DiabetesMine at the time 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.

However, with this latest FDA interchangeability development, it’s unclear how the pricing may change once this latest Semglee product is released in late 2021.

Mylan is now part of Viatris, and that company’s head of global communications Lauren Kashtan told DiabetesMine that it isn’t disclosing pricing information until closer to the re-launch.

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,” then-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.