High on the wish list for PWDs is cheaper insulin. Costing over $100 a bottle (without insurance), this life-saving liquid can drain your bank account faster than your blood sugar goes up after a bowl of cereal. With so many over-the-counter and prescription drugs going generic and finally saving patients hundreds of dollars, naturally we’re wondering, “When on earth are we gonna get generic insulin?”
Sadly, probably not anytime soon.
Bio-What?
In fact, there really won’t ever be “generic insulin.” At least, not the way most people think of it. The term “generic” is used to describe drugs that are essentially copycats of another drug. For instance, aspirin or ibuprofen comes in many different shapes and sizes, but it’s all the same drug. They all have the same active ingredient.
Insulin, however, is special. Insulin is a biopharmaceutical, which means drugs made using biotechnology, employing complicated bioprocesses, and including things like proteins, nucleic acids (DNA and RNA), living organisms, viruses and bacteria. Fun fact: “Human” insulin was the first biopharmaceutical product approved for therapeutic use. It was made using recombinant (or replicated) DNA technology… and sold under the brand name “Humulin” by Eli Lilly starting in 1982.
- Aspirin
Other things that are considered biopharmaceuticals include glucagon, growth hormones, and vaccines.
So how come we can’t have generic insulin? Biopharmaceutical drugs are much larger and more complicated to reproduce perfectly in a laboratory. The images to the right show the comparison between the insulin molecule and the aspirin molecule, for example.
Dr. Richard Dolliner, at Health Affairs Blog, the leading journal of health policy thought and research, explains why biosimilars can’t be considered generics: “Because biosimilars do not utilize the same living cell line, production process, or raw material as the innovator drug, they can never be made ‘identical’ to the innovator biologics. This matters because small differences in molecules can result in major differences in the drug’s clinical efficacy and safety.”
Or another way to think of it: it’s like trying to duplicate a recipe from a restaurant. You might follow the recipe precisely, but there will be variations in the ingredients and the manufacturing process that will always make your food taste different from the restaurant’s original.
This is extra important in the medical world because since biosimilars are similar, not identical, they might not be considered interchangeable. That is, your pharmacist couldn’t automatically make the switch between your current insulin and the new biosimilar insulin. If that’s the case when biosimilar insulins are finally FDA approved, that means they’d require their own separate marketing and sales teams to educate providers and patients. Which costs more money. A lot of money.
The FDA and Biosimilars
Unfortunately, even though biosimilars hope to be an alternative to the original drug, they will still require a heavy amount of oversight from the FDA, including monitoring of manufacturing facilities, and the manufacturing process will still be intensive.
In February, the FDA released three draft guidelines on biosimilars, mainly focusing on how companies should go about applying for approval and what requirements they can expect. A biosimilar insulin will need to be essentially the same as current insulin, with no adverse events found. The FDA draft guidelines require analytical studies to be done, with animal and human clinical trials to be done on a case-by-case basis.
On Tuesday, I attended a webinar on biosimilars held by the Chicago law firm McDonnell Boehnen Hulbert & Berghoff LLP. During the webinar, Dr. Kevin Noonen explained that there were no “clear rules” that came from the draft guidance. “The FDA has given themselves maximum flexibility,” he said.
Notably absent in the FDA guidelines are the issues of interchangeability and branding, including naming and labeling. Noonen says these issues are “likely to be addressed later.”
For those interested, the FDA is currently accepting public comment on the draft guidance until April 11th, and there will be a public hearing on May 11th.
On pricing: As of right now, industry experts predict prices for biosimilar insulin to run about 30-70% of the cost of the original drug, whereas typical generic drugs are around 10% of the original price. In Europe, current cost savings on biosimilar drugs approved there are only about 10%. So biosimilar insulin will be cheaper, but it won’t be as cheap as other generic drugs.
The Future of Biosimilar Insulin
Unfortunately, we are bearers of some sad news: the biggest Pharma player planning to introduce biosimilar insulin has dropped out. It seems like only yesterday that we were reporting on the new partnership between Pfizer and India’s Biocon to develop biosimilar insulin together. But as of this month, that partnership has come to end. Each company says there are plans to continue work on biosimilar insulins, just not together, which undoubtedly indicates delays.
In a recent interview, Pfizer’s Chief Medical Director, Kiran Mazumdar-Shaw said, “Pfizer is dedicated to developing a portfolio of biosimilars including monoclonal antibodies and recombinant proteins. Biocon is committed to deliver a biosimilar insulin portfolio to diabetic patients. It’s in the best interest of both the companies to pursue their individual priorities.”
- Sanofi trademarked this group a few years ago, but seems to have abandoned it
So who will bring biosimilar insulin to market first in the U.S.?
Scott Strumello, the DOC’s resident dia-business expert and someone who has followed this issue closely, says other possible major players could be the Sandoz unit of Novartis, Elona Biotech (founded by two former Lilly execs) and Teva, a pharmaceutical company currently investing in research for a compound called DiaPep277. Indiana-based Elona Biotech made the ambitious announcement in 2010 that it is developing its own manufacturing plant for biosimilar insulin. Meanwhile its neighbor, insulin giant Eli Lilly, doesn’t seem terribly interested in biosimilar insulin; they make $3.6 billion on their branded insulins every year.
Because of the costs to create, approve and market this new drug, the president of Lilly’s diabetes division, Enrique Conterno, told the Indiana Business Journal about the small firm Elona Biotech: “We don’t believe that they’re going to be highly successful.” Hmmm.
Sandoz is already a major player in biosimilars, with two biosimilar products (growth hormones) already on the market. Teva has vested interested in the biosimilar market, and with its investment in DiaPep277, they are potentially another player for developing biosimilar insulin.
The breakup of Pfizer and Biocon was certainly a setback, but with more patents on current insulin products lifting within the next three years (Humalog goes off-patent next year), it’s likely that more interest will develop. There are certainly hurdles in this field of research, but as many people have pointed out, with 250 million people worldwide with diabetes, there is unfortunately no shortage of need. Hopefully that need will someday cost a little less.
The reason insulin is so expensive in the USA is because big Pharma has influenced the laws so that we, the people have no choice but to pay them whatever they ask.
If we as diabetics actually started expressing our outrage at this and stopped acting as if it’s just the way things are, then we wouldn’t have to place our hopes on biosimilarity or anything else.
Here is a price list for Novolog insulin from Canada. It’s basically 45 bucks a bottle, which is $84 cheaper than what I pay my Pharmacy (or my Pharmacy bills my insurance for and they pay) at $129 per pop.
Of course, it’s illegal for us to order insulin from Canada. Hmmmm. I wonder why. it’s the same product.
http://www.northwestpharmacy.com/ProductSearch.aspx?mid=b1a75b5a5200437cbb9efa4c0b6787df&s=novolog&DrugID=71689
Novolog Insulin Vials (Insulin) 1x10mL (1 vial) 10.00 ml $44.99
Novolog Insulin Vials (Insulin) 1x10mL (3 vials) 30.00 ml $134.97
Novolog Insulin Vials (Insulin) 1x10mL (5 vials) 50.00 ml $224.95
Novolog Insulin Vials (Insulin) 1x10mL (10 vials) 100.00 ml $449.90
Hi Jay, we actually covered the issue of buying insulin from Canada last fall. Check out the post here: http://www.diabetesmine.com/2011/09/true-or-false-you-can-buy-insulin-from-canada.html
I use Apidra in my pump. Currently its manufacturer seems to be running some sort of a special. I paid $60.00 for three bottles on my last few visits to the pharmacy. I don’t know if it’s because they are trying to drum up business, or what, but check with your local pharmacy to see what’s up. I was definitely told that the manufacturer is absorbing the rest of the cost (and I do have good health insurance, so it’s not that they took pity on me.)
I would say, “be careful what you wish for.” I’d rather more expensive insulin if the alternative is a biosimilar that is variable in its efficacy.
I have a certain skepticism about generics, and these biosimilars seem like they carry greater risk than do generics.
Yes, I read the article on buying insulin from Canada…it showed up when I did a search for that, if I remember correctly:) Very helpful.
Interesting about Apidra. I am not familiar with that insulin. Is it similar to Novolog?
I am looking for a way to stock up on insulin in case of emergency–natural, financial, you name it. Insurance is not just having someone pay someone else for your supplies. The world is unpredictable these days. And perhaps in an emergency you might have to share with someone else in need. I’d like to have several months of supplies. I know that sounds extreme but at 2 bottles per month, that’s only 6 bottles or so. it’s also expensive. It’s tricky to get prescriptions to work for purchasing backup, supplies. Why?
I have an unusual insurance plan, in that I have to purchase my supplies first, and then get a reimbursement check from the agency (once i meet my deductible) As a result, I get to experience the actual price that the pharmaceuticals are charging the insurance company. I know that most people are shielded from this because when I pull out my debit card to pay for my supplies, the pharmacist always shakes his head or does a double take if he’s new, because it seems like an outrageously high copay.
It never ceases to amaze me how the price of every thing I have no choice but to purchase continually, continually, continually goes up, month to month, year to year, at a much, much MUCH faster rate than anything else I pay for.
It is quite simply, outrageous. There’s no other word for it. This isn’t inflation, it’s profiteering.These companies might be making good products, but they are also fleecing us and our insurance companies and the entire healthcare system for all its worth. I would call it equivalent to charging the Pentagon $400 per bolt, because they have a captive audience and the people who are actually using the products are not the ones dealing with the prices.
If more people were in my situation, I think there would outrage. That’s where I stand on this and I wish there was something that could be done about it.
June, I signed up on Apidras website and I get my insuling for free right now until the end of the year. I can only get 2 bottles of insulin each month and I can’t use mail order, I have to go to the drug store each month, but I get free insulin until the end of the year. It is worth looking into!!!
Jay, I used to use Novolog but switched to Apidra because my doctor said it is easier on scarring rather than Novolog/Humalog does and after 28 years of insulin sites/infusion sets/CGMs, I have a lot of scarring.
[...] The Biosimilar Promise of Less Expensive Insulin (diabetesmine.com) This entry was posted in In the News and tagged Biosimilar, Chief Scientific Officer, Covance, Eden Biodesign, Frank Gallagher, Genetic engineering, Insulin, Shameless by . Bookmark the permalink. [...]
Anyone checked the price now. Checked with 3 Canadian pharmacies. $259.00 a vial !!!!!!
I did. Shocking isn’t it?
This huge increase could have only come from drug manufactures. The big quesiton is why. answer is the assumption that everyone in America will soon have health/drug insurance and they won’t. Canadians don’t pay for health care. It is all free including their drugs.
I just sent an email to a canadian pharmacy asking for an explanation of why the cost of OTC insulin is now almost $260 a bottle. When I get a response I will post it here.
INTERESTING. They JUST lowered the price by over $70 a bottle. Weird goings on. It is now $188.49 which is still OUTRAGEOUS.
.
If my opinion matters on this subject, applicants for biosimilar insulin can apply today by law, and the reason is because insulin is grandfathered under the Federal Food Drugs and Cosmetics Act, and that does not require the product to be an exact copy to gain approval. Witness what happened with Onmitrope from Sandoz (part of Novartis) a few years ago. By the way, several years ago, I wrote about how Express Scripts did a report on so-called “biosimilars” (see that post at http://bit.ly/Z2YgnU) and based on that data, my conservative calculation was that biosimilar (“generic”) insulin could save $797 million in the first year alone, and totaling in excess of $16 billion over 10 years. To be sure, the FDA should be permitted to release its final guidance on biosimilars which are now mandated by law under the Affordable Care Act. Draft Guidance was released a year ago, and many of us commented on that, but the FDA is likely to release final guidance shortly. In the end, biosimilars WILL arrive, the key is whether a) the law permits automatic substitution. Legislation now pending in Illinois would mandate substitution regardless of what the FDA outlines in the final guidance (BAD IDEA, Illinois!!! Very bad!). In my comments to the FDA, I told them I wanted better disclosure labeling from pharmacies of the underlying manufacturer, and also that patients deserve a minimum of 120 days following advance notice from pharmacy benefits managers (e.g. Express Scripts and the like) to fill their last order before the old biosimilar is replaced with a new one. We shall see what’s in the final FDA guidance in the not-too-distant future.