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 companies, 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 two 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” — a term often used interchangeably, but indicates a “copy” of a biologic that is approved by the U.S. Food and Drug Administration (FDA).
You can learn more about the specifics of these terms in this recent
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 copy and 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. And 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 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.
What it costs and who benefits: Basaglar generally costs about 15 percent less than Lantus. Since the cost savings are minimal, it’s been referred to as “the expensive Lantus ‘generic.’” Frustrating.
Basaglar is available on many commercial insurance plans. And Lilly offers a Patient Assistance Program for Basaglar, like its other medications.
Pharma companies Mylan and Biocon announced in June 2020 they had received FDA clearance for their new Semglee basal insulin, which 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.
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. Pricing details weren’t yet finalized at the time of regulatory approval, but Mylan expects to finalize launch plans by the end of 2020.
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.
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.
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.
Unfortunately, the price difference between biosimilars and the insulins they’re copying has been disappointingly small to date.
However, there may be hope for new, cheaper insulin coming from some dedicated biohackers based in the San Francisco Bay area.
Since pharma companies aren’t doing a good job of making affordable insulin, the Open Insulin Project wants to help people make it on their own. The project is working on what it calls a “freely available, open protocol” for the production of low-cost insulin. Think of it as do-it-yourself generic insulin for independent developers.
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 got initial funding in 2015 and have recently gotten a lot of media attention. But it’s too soon to predict if, and when, they’ll make a big difference in the lives of PWD.
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.
Since we’re talking about cheaper insulin, Novo Nordisk’s Novolin ReliOn brand deserves a mention here. Sold for just $25 a vial without a prescription at Walmart, ReliOn includes “Regular” (short-acting), NPH (longer-acting), and 70/30 (biphasic insulin), a combination of the other two.
These ReliOn products are not generics or biosimilars, but rather older “human” insulins — as opposed to the newer “analog” versions being produced today. Many patients and doctors agree that these older formulations clearly don’t provide the same level of blood glucose management as newer insulins.
But if you’re forced to choose between using them and doing without or rationing insulin, these older insulins are certainly preferable.
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.