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 true for insulin?
Especially at a time when people with diabetes (PWDs) are desperately rationing this life-sustaining drug due to astronomical pricing?
Blaming this situation on the greed of the three main insulin manufacturers — Eli Lilly, Novo Nordisk, and Sanofi — is too simplistic, although it would be partly accurate.
Two other important factors are holding back widespread availability of affordable generic insulin: the complexity of the drug itself and its production process, and the equally complex (and deeply flawed) U.S. healthcare pricing system.
Read on to learn about why there aren’t more cheaper insulins, which options are available, and who benefits most.
What is ‘generic’ insulin? Meet the biosimilar
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 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 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.
It costs a lot to copy insulin
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, which have smaller molecules. That has discouraged competitors of the major insulin manufacturers from entering the market. As John Rowley of the advocacy org 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 is 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
Patent system discourages new biosimilars
The U.S. patent system — or the way pharma companies manipulate it — is another barrier to cheaper versions of existing insulin brands.
Specifically, drug manufacturers have repeatedly made lots of little changes to existing insulin products in order to apply for new patents on them. This process, called “evergreening,” has discouraged competitors from developing new versions of existing insulin types. So have “pay for delay” deals, in which insulin manufacturers pay competitors to not copy specific drugs for a period of time.
Copycat insulins now available. Who benefits?
Despite these obstacles, some cheaper versions of older insulin brands have become available to consumers in recent years, including:
This is Lilly’s own low-cost version of Humalog, its bolus (short-acting) insulin cash cow. Released in March 2019, 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% 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 the company, 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.
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 (fast-acting) insulin on the market. But, alas, it cost about only 15% 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% 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 companiesMylan and Biocon collaborated on this version of Lantus that has been approved in Europe, Australia and other countries (with different brand names) but it has not yet been approved in the United States.
Are copycat insulins the same as originals?
Only one so far is identical: Lispro, made by the same company that produces the original, Humalog.
Remember, the FDA just requires biosimilars/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.
Will new biosimilar insulins save the day?
There are a few other biosimilar insulins under development. The FDA is supposedly trying to encourage copycats of biological products with even more changes to the regulatory approval process, scheduled to take effect in March 2020. But the jury is still out on what that’s going to mean for insulin.
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 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.
Attempting homemade, open source insulin
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 PWDs.
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.
What about ‘Walmart insulin’?
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.
Bottom line: The insulin pricing crisis continues
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.
This article has been medically reviewed by Maria S. Prelipcean, MD, on 8/14/2019.