The Crazy Reasons Why Affordable, Generic Insulin Doesn't Exist
There always seems to be a cheaper, generic brand for anything you might need; they are made of the same ingredients and sold in similar packaging. So why do we not have an affordable generic version of insulin?
We need this now more than ever, with skyrocketing prices, people having to ration and struggle to afford this life-sustaining drug.
While it might be easy to blame this situation on greed and the monopoly of the three leading insulin manufacturers: Eli Lilly, Novo Nordisk, and Sanofi, that is too simple, although they are partially to blame, the problems causing these issues are much more complicated.
Two key factors are delaying the availability of generic insulin. The first one being the complexity of the drug and the associated production processes. With the second being the complex and flawed U.S. Healthcare pricing system.
'Generic' insulin, meet biosimilar
If you have done any research about generic insulin, you will eventually come across some technical language that is tossed around like a joke at a party. But there are only a few terms you need to know to understand the technical jargon.
- Biologic. Modern insulin is known as a "biologic," which is a category of medications with large, complex molecules, made from living material.
- Biosimilar: This is what a companies copy of a biologic is known as since it is not technically a "generic" drug. It is instead similar or follow-on medicaiton that indicates it is a copy of a biologic that has been approved by the FDA.
If you are so inclined, you can learn more about these terms and how they apply to insulin here: Journal of Pharmacy Technology.
There is a difference between these formulations and true generic medication. Generic medications are designed to use the same active ingredients and work in the same way as brand name medications.
Where Biosimilars are only highly similar to the insulin products, they are based on. They have the same safety, purity, and potency needed to be considered equals, but are not made from the same formula as the original drug.
It's Expensive to copy insulin
This is one of the most frustrating reasons that there aren't copycat insulin's on the market.
It is almost entirely cost-prohibitive and complex to copy and reproduce a biologic compared to simpler medications like Advil. This factor alone has discouraged many competitors of the major insulin manufacturers from entering the market. It is almost cheaper to create a new drug rather than attempt to copy one.
The next equally complex and expensive hurdle is the FDA's approval and review process for biosimilars and follow-ons, which can be much more elaborate than the process required for the simpler generic medication. Even with the newly approved "abbreviated approval pathway," known as the Biologics Price Competition and Innovation Act.
U.S. Patent system discourages new biosimilars
The U.S. patent system, and the way big pharma companies can manipulate it builds more barriers for cheaper versions of existing brands.
Drug manufacturers have consistently made lots of minute changes to existing insulin products as patents expire, allowing them to get new patents. This is known as "evergreening" and is a serious discourager to competitors trying to develop new versions of insulin types that already exist. Even with this speed bump, some of the larger manufacturers will also pay competitors to delay or cancel their products entirely.
Copycat Insulin Does Exist
Even with these obstacles in place, there are some cost-effective versions of name brand insulin that have made it to market in the past few years.
This is a low-cost version of Humalog, made by Lily. It is bolus insulin or short-acting insulin. It was announced in March 2019 and launched two months later. While it's not a biosimilar, it is instead an authorized generic. This makes it identical to Humalog; basically, all Lily did was put a new label on an already existing drug. They say they would have done this sooner, but it was delayed because of government regulations.
What does it cost and who does it benefit: The list price of this specific insulin is nearly 50% lower than that of Humalog, the price currently hovers around $137. (Although many things that it should still cost much less.)
Insulin Aspart and Insulin Aspart Mix
This is Novo Nordisk's lower-cost version of its NovoLog and 70/30 mix, both mealtime insulin brands. Just announced on Sept. 6, 2019, these authorized generics are 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 will be 50% lower than that of NovoLog and 70/30 mix (such as $144.68 per 10mL vial, compared to $280.36 for NovoLog). According to the company, these half-price versions will start becoming 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 (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 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.e'" Frustrating.
Basaglar is available on many commercial insurance plans. And Lilly offers a patient assistance program for Basaglar, like its other medications.
Are Copycats The Same?
So far, there has only been one identical insulin developed. It is known by the brand Lispro and is made by the same company that produces the original, Humalog.
When you are looking into copycat insulin, it is important to remember that biosimilars are only required to be "highly similar" to what they are copying. If you are thinking of substituting one of these medications, it is essential to talk to your doctor in case the dosage needs to be adjusted.
Will new biosimilar insulins save the day?
Currently, there are various other biosimilar insulins under development. There is a lot of encouragement coming from the FDA for companies to come up with copycats of biological products. Now with even more changes coming to the approval process in 2020, the jury is still out on how this will affect the cost of insulin and copycat products.
In recent years there have been bills introduced in the Capitol to attempt to curb the amount of evergreening and pay-for-delay deals that have severely impeded copy cat insulin and its development.
Currently, the price difference between biosimilars and the insulins they're copying is disproportionately small, and in many cases, quite underwhelming.
Attempting homemade, open-source insulin
In the past decade, there has been a meteoric rise in people trying to "bio-hack" themselves to be smarter, healthier, and even try to cure diseases. This has now spread into the insulin and diabetes market as the Open Insulin Project. Which wants to make it possible for people to produce insulin on their own. It is designed to be freely available and open protocol for the production of low-cost insulin. It can be better described as do-it-yourself generic insulin for developers.
The project's founder Anthony Di Franco has diabetes himself. His vision is to move production away from pharma companies into small collectives of clinics and hospitals. Places where insulin can be manufactured in platforms that would only cost as much a car.
There has been only slight progress since the initial round of funding in 2015. But in the past few years, they have gotten a lot of media attention. However, it is too soon to tell if and when it will make a difference in the lives of people with diabetes.
Even if they do develop a protocol for homemade insulin, it will be severely limited by the cost of regulatory approvals, which include biological consistently, safety, and possibly efficacy.
While it is worth keeping an eye on this program, it is unfortunately highly unlikely that this method will solve the insulin pricing problem that people with diabetes are currently facing.
What about 'Walmart insulin'?
While we are on the subject of cheaper insulin, Novo Nordisk's Novolin ReliOn brand is worth a quick discussion. It is currently sold for around $25 a vial at Walmart without a need for a prescription. It comes as a combination of regular (short-acting) and NPH, which is a long-acting insulin.
These products are not generic or biosimilar, but instead older insulin that is not like some of the newer "analog" insulins on the market. While it is a promising compromise for those who are struggling to afford insulin, It is much less effective and doesn't provide the same level of blood glucose management.
The Stark Truth:
The insulin pricing crisis continues
While there are promising alternatives and legislation that will help to reduce the cost of insulin coming, it doesn't appear that the large manufacturers of insulin are going to lower prices voluntarily. This is a grim reality that should motivate diabetes advocates and "biohackers" to both do more with politics, and work to create alternative ways to manufacture insulin or cure diabetes.
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