These days, all sorts of medications seem to come in cheaper off-brand versions made of the exact same ingredients, known as “generics.” So why isn’t this the case for insulin?
Especially at a time when people with diabetes (PWD) are desperately rationing this life-sustaining drug due to astronomical pricing, this question becomes even more pressing.
The fact is that the term “generic” has been loosely applied to copycat versions of name brand insulins sold at lower prices, or to older, less reliable forms of human insulin. Some may believe “generic” insulins actually do exist, including insurance company reps, pharmacists, and others in the diabetes community who may echo this messaging.
But the reality is there are no true generic insulins available — defined as chemically identical to brand-name products and with the same efficacy, but sold much at much cheaper prices.
The three main insulin manufacturers — Eli Lilly, Novo Nordisk, and Sanofi — can be blamed for some of this. But they’re not the only entities who’ve stood in the way of widespread availability of more affordable generic insulin. That’s too simple. Complexities of the drug itself, the use of the U.S. patent system, and the deeply flawed U.S. healthcare pricing system are all to blame as well.
Read on to learn why there aren’t cheaper insulins, which options are available, and who benefits most.
When researching generic insulin, you’ll inevitably be confronted with a lot of technical language that regulatory folks toss around. Have no fear. There are just a few terms you really need to know:
- Biologic: Modern manufactured insulin is a “biologic,” a category of medications with large, complex molecules, made from material that comes from living organisms.
- Biosimilar: When one company tries to copy another company’s biologic, the new one is not technically a “generic” drug. Rather, it’s called a “biosimilar” or a “follow-on” — terms often used interchangeably that indicate a “copy” of a biologic that is approved by the U.S. Food and Drug Administration (FDA).
- Authorized generic: This is another complicated term, because it specifically uses the word “generic” but does not refer to a true generic as most people know them.
Per the FDA, an “authorized generic” is an approved brand name drug that is marketed without the brand name on its label. Otherwise, it is the exact same drug as the branded product. Think of it like water coming out of the same tap, but one going into a brand name bottle and the rest going into a separate container with a different label.
What’s important to know is the difference between these formulations and true generics: “Generic medications use the same active ingredients and work the same way… as brand-name medications,” according to the
Biosimilars, on the other hand, must be “highly similar” to the insulin products they are based on. This means the safety, purity, and potency need to be equivalent, but they are not made with the identical recipe of the original drug.
So why aren’t there more copycat insulins?
By and large, it’s more complicated and expensive to reproduce a biologic than to duplicate simpler medications like Advil for example, which has smaller molecules. This has discouraged competitors of the major insulin manufacturers from entering the market. As John Rowley of the advocacy organization T1D International puts it, “They have to spend almost the same amount of money to produce a biosimilar as they would a novel drug.”
Another hurdle has been the FDA’s approval process for biosimilars and follow-ons, which is more elaborate and demanding than the process used to approve simpler generic medications. That’s true even though Congress created an “abbreviated approval pathway” in 2009 when it passed the
On March 23, 2020, the
This doesn’t present any immediate advantages to PWDs using insulin. But the hope is that eventually, this new regulatory categorization will make it easier and less costly for new companies to develop and market new, cheaper insulins.
The U.S. patent system is another barrier to cheaper versions of existing insulin brands.
Specifically, drug manufacturers have repeatedly made lots of little changes to their existing insulin products in order to apply for new patents on them. This process, called “
Despite these obstacles, some less-expensive versions of name-brand insulins have become available to consumers in recent years, including:
This is Eli Lilly’s own low-cost version of Humalog, its bolus (short-acting) insulin cash cow. Announced in March 2019 and launched in May of that year, it’s not a biosimilar, but rather an “authorized generic” according to the FDA. That means it’s essentially identical to Humalog. All Lilly did was slap a new label on an existing brand — a move they say they would have liked to have done earlier, but they first had to grapple with cumbersome government regulations.
What it costs and who benefits: The list price of Lispro is 50 percent lower than that of Humalog, which makes it currently about $137 per vial. (Many diabetes advocates insist it should cost a lot less.) According to Eli Lilly, the patients most likely to benefit from it are Medicare Part D beneficiaries, people with high-deductible health plans, and the uninsured who currently use Humalog.
Insulin Aspart and Insulin Aspart Mix
This is Novo Nordisk’s lower-cost version of its NovoLog and 70/30 mix, both mealtime (fast-acting) insulin brands. Announced on September 6, 2019, these authorized generics are exactly the same as NovoLog and mixed insulins, except with a different name on the label.
What it costs and who benefits: The list price of Insulin Aspart/Insulin Aspart Mix in both pen and vial options are 50 percent lower than that of NovoLog and 70/30 mix (such as $144.68 per 10mL vial, compared to $280.36 for NovoLog). These half-price versions became available in January 2020, and the patients most likely to benefit are those on high-deductible health plans and the uninsured who currently use NovoLog or 70/30.
This is yet another version of Humalog, but it’s a biosimilar made by a competing company, Sanofi.
What it costs and who benefits: When it was released in April 2018, Sanofi proclaimed that Admelog had the “lowest list price” of any mealtime insulin on the market. But, alas, it costs about only 15 percent less than Humalog, as DiabetesMine reported.
That said, it’s more available than Lispro to people with commercial insurance. In May 2019, Sanofi announced their ValYou Savings Program, which offers deals on Admelog and its other insulin brands for those who don’t qualify for its other Patient Assistance Programs.
This follow-on version of Sanofi’s basal (long-acting) Lantus insulin was introduced in the United States by Lilly and Boehringer Ingelheim in December 2016. In the U.S., it’s technically called a follow-on insulin because of its regulatory pathway, while in Europe, it’s considered a biosimilar.
Basaglar is available on many commercial insurance plans, and Lilly offers a Patient Assistance Program for Basaglar, like its other medications.
Semglee (glargine) and interchangeability
Semglee basal insulin from Mylan and Biocon received FDA clearance In June 2020. It is the second knockoff of Sanofi’s Lantus long-acting insulin. This insulin had been approved in Europe, Australia, and other countries under different brand names before finally getting a green light for sale in the U.S.
Importantly, in July 2021 the FDA cleared Semglee as an “
What it costs and who benefits: Semglee is FDA-approved for children ages 6 to 15, as well as adults with both type 1 and type 2 diabetes. It will come in U-100 concentration in both 10mL vials, as well as 300-unit, prefilled insulin pens with one-unit dosing increments.
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 five pens. 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
Some industry-observers speculate that this interchangeable type of insulin could lead to significant change and lower cost insulin across the board, if payers are motivated to switch to the less-expensive versions rather than the higher list-priced versions. But that remains to be seen, and not everyone agrees that interchangeability can make the impact some are hoping for.
Only one so far is identical: Lispro, made by the same company that produces the original, Humalog.
The FDA only requires biosimilars or follow-ons to be “highly similar” to the medications they’re copying, but not identical. So if you want to substitute a copycat insulin for the type you’re using now, it’s important to work with your healthcare provider to determine if the dosage needs to be adjusted a bit.
Since established pharma companies aren’t doing a good job of making affordable insulin, there are a flurry of others who believe they can do better, including the early-stage development company BiologX formed in November 2020 with an aim to create lower-cost “generic” insulin.
Based in Austin, Texas, this new startup is made up of venture capitalists and biotech pharma folk. Their marketing slogans sound appealing: “Making insulin affordable to save lives!“
How much more affordable? The company’s CEO David Woods says it will be 70 percent less expensive than current branded insulins, and the investment firm Manhattan Street Capital claims the price tag will be $25 to $50 per vial.
From the company’s website they appear to be first developing older human insulins in biosimilar form, which could be delivered via insulin pen or insulin pump, before eventually moving into the analogue versions that started appearing in the late 90s and early 2000s.
Biologx is not publicly stating any specific launch dates, but the startup’s leadership says the FDA’s expedited approval process for biosimilars could mean they’d be available within 24 months once they get enough funding.
Other outfits that have appeared over the years promising to change the insulin landscape, but that hasn’t ever materialized because this isn’t an easy industry to getting a footing in.
There is also a notable DIY project tackling this issue, known as the Open Insulin Project in the San Francisco Bay Area. Their team is working on what it calls a “freely available, open protocol” for the production of low-cost insulin.
The project’s founder, Anthony Di Franco, lives with type 1 diabetes himself. He envisions moving production away from pharma companies to “small collectives or pharmacies, clinics, and hospitals” where insulin can be manufactured in platforms that would cost only about as much as a small car.
The group has made some progress since they raised initial funding in 2015 and have gotten a lot of media attention, but so far it’s all still experimental.
Even if they develop a protocol for home-brewed insulin, according to experts at Colorado State, the success of the project will be “severely limited by the cost of regulatory approvals, which include proving biological consistency, safety, and possibly efficacy.”
It’s worth keeping an eye on these intrepid pioneers. But sadly, it doesn’t seem likely that they’re going to solve the insulin pricing crisis in the very near future.
There are a few other biosimilar insulins under development, and the jury is still out on whether the FDA’s change in March 2020 on biosimilar insulin classification will make a difference in allowing more competition. Or whether the interchangeability designation on Semglee in 2021 will impact big change.
Bills have been introduced on Capitol Hill to curb the evergreening and pay-for-delay deals that have hampered copycat insulins, as we noted in this rundown of “the government’s big ideas to bring insulin prices down.” But the jury is still out on those, too.
In its insulin affordability position statement from January 2021, the Endocrine Society notes that it will be up to other insulin developers to enter the market and motivate more change toward lower prices.
“For biosimilars to have an impact on the price of insulin, availability must extend beyond current manufacturers and new companies must be willing to undertake a costly development and strict review process,” the organization wrote.
Since we’re talking about cheaper insulin, Walmart’s ReliOn brand deserves a mention here.
Walmart has sold its private label of ReliOn insulin since 2000, with Novo Nordisk’s insulin being the co-branding partner for most of those years — except for 2010 to 2012 when Eli Lilly nabbed the contract for its insulins to be co-branded as ReliOn.
Until mid-2021, the only so-called “Walmart insulin” you could get for a lower price (roughly $25 to $35 per vial) was the older, human versions of insulin — R (or Regular) insulin, N (which is Novolin, aka NPH insulin), and a 70/30 mix of the two other types.
Those formulations have been around since the early 1980s, but they work much differently and are seen as much less reliable than the analog insulins that first appeared in the late 1990s, and are considered standard these days: Humalog or Novolog rapid-acting, and longer-acting basal (background) insulin including Lantus, Levemir, Tresiba, or Toujeo.
But in June 2021, Walmart announced it would be adding the rapid-acting Novolog to its lower-cost insulin lineup. This version of Novolog insulin costs between 58 and 75 percent less than the current cash list price at most retail pharmacies:
- $72.88 per glass vial (10mL each, or 1,000 units)
- $85.88 for a box of five FlexPens (each with 3mL, or 300 units)
This can allow many PWDs to get this life-critical medication without insurance, an important factor given the number of uninsured and underinsured, and those struggling with high-deductible insurance plans.
When we survey the landscape of realistic alternatives to the current batch of high-priced insulins, it doesn’t appear that insulin manufacturers — either big corporations or intrepid rebels like the open-source folks — are going to be providing much relief in the near future.
That grim reality should motivate diabetes advocates to do more in the political arena and keep the pressure on federal and state governments to make insulin more affordable and accessible.