While COVID-19 has distracted our attention from affordable insulin to focus on social distancing and hoarding toilet paper, the U.S. Food & Drug Administration is finally making a serious effort to improve our access to insulin.
Why no Generic Insulins?
A long-standing issue with insulin is the lack of a “generic.” Just like you can buy generic metformin instead of Glucophage, or your grocery store’s brand of acetaminophen instead of Tylenol, we ought to be able to buy a generic version of long-acting and rapid-acting insulin that may not be as awesome of Fiasp or Novolog or Tresiba, but it still gets the job done.
Sanofi, NovoNordisk, and Lilly have created huge and profitable businesses by filing hundreds of patents for every type of insulin in order to prevent generics from being legally possible.
The FDA is finally changing that.
FDA Changes
“On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act,” explains a recent report from the FDA.
“This will, for the first time, enable submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. As such, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition.”
In other words: any pharmaceutical companies will be legally allowed to produce more affordable versions of today’s most advanced insulins.
“The availability of approved biosimilar and interchangeable insulin products is expected to increase patient access, adding more choices and potentially reducing costs of insulin products,” adds the report.
FDA Goals for New Regulatory Framework
The FDA Commissioner, Stephen M. Hahn, M.D., acknowledges that today’s patent laws around biologic drugs like insulin have resulted in little competition in the marketplace and more expensive drugs.
The only people who pay the true price for the current system are the patients who desperately rely on those drugs in order to stay alive.
“This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace,” explained the commissioner.
“These critical therapies often carry a heavy price tag; the cost of insulin has risen over the past decade. Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these life-saving drugs. We will continue to communicate relevant information, including the resources we’ve issued today, to make the transition from one statutory framework to another as seamless as possible.”
While it’s certainly felt like the FDA has done very little to actually improve the outrageously rising prices of insulin until now, they’ve apparently been establishing the legal framework for this to become possible since 2018.
The “Biosimilars Action Plan (BAP)” was issued in 2018 to improve the overall regulatory process of biosimilar and “interchangeable product development” — also known as more affordable generic versions!
Of course, this isn’t just to improve the affordability of insulin, but of many other drugs for which there is little competition due to a ridiculous number of patents, even on older insulins like Lantus.
Lantus Example
The price of Lantus insulin has increased by 49 percent over the last 20 years — an increase that cannot be justified by inflation alone — according to a study from the University of Pittsburgh.
While the original patent for Lantus expired in 2015, dozens of “secondary patents” prevent competitive alternatives from being developed and marketed to the public.
This web of secondary patents is the work of powerful legal teams behind every pharmaceutical giant. This results in extending by years and years the high profits of protected products.
This secondary patent strategy is used by all pharmaceutical companies.
For example, the generic version of metformin is actually inadequate because it doesn’t offer an “extended-release” version which ameliorates its harshest side-effect: digestive discomfort and diarrhea.
But Glumetza, an extended-release version covered by secondary patents, will cost a patient as much as $600 a month versus the few dollars a month they’d pay for metformin.
Biosimilar Drugs ‘Interchangeable Products’
The FDA’s most recent effort will change the finer details of the laws surrounding biosimilar drugs like insulin and make “interchangeable products” more easily available because other pharmaceutical companies will be more easily able to develop and market them.
“The FDA’s interpretation of the transition provision of the BPCI Act is intended to balance innovation and competition and facilitate the development and approval of biosimilar and interchangeable products,” explains the FDA’s report.
“Getting safe and effective biosimilar and interchangeable products approved will help ensure that the market is competitive, and patients may have more affordable access to the treatments they need.”
The FDA also emphasized that when generic, more affordable options become available, they shall be managed in a way that minimizes any noticeable interruption or differences for the patient in how they receive or take their medications.
As people with diabetes, we know that no two insulins are exactly alike, even if they exist in the same category — like Humalog vs. Novolog vs. Fiasp. Yes, they’re close, but for some, the differences are noticeable. Personally, I’ve been on Fiasp for just a few weeks and I absolutely need far less of it to correct a high blood sugar (for example) than I need of Novolog.
We’ll have to wait and see what this approach to more generic “interchangeable” insulin really looks like when it truly arrives on the market.
