Novo Nordisk Will Sell An Unbranded Version of Tresiba in the U.S.

Sometimes communicating the right message to the right party at the right time may result in a pleasantly unexpected thing happening!

During this year's EASD which took place in Stockholm, Sweden (a beautiful city I've visited more than a few times over the years), at the end of a Live Tweet event with Novo Nordisk Live @NovoNordiskLive, I shared a few thoughts which had been bothering me about Novo Nordisk's commitment to its U.S. unbranded insulin strategy (I described its commitment as "half-hearted"), and I did so by sharing several slide images which I got directly from Novo Nordisk's quarterly investor presentations and the company's 2021 annual report.

 

 

 

 

 

 

 

 

Frankly, I did so because I felt as if the Danish company was simultaneously boasting to company investors about how much "assistance" the company's affordability options in the U.S. were providing, while also doing so for essentially a single product (unless you include its pre-mixed insulin varieties which are not very big sellers anyway). In my mind, that was hardly a corporate commitment to the company's unbranded insulin strategy.

And yet, at the same time, Novo Nordisk is one of the biggest contributors to the PBM rebate problem responsible for runaway U.S. insulin prices in the first place. By last disclosure, Novo Nordisk revealed that the company was paying PBM's 74% rebates of its gross U.S. sales in order to keep competing products off many insurance company formularies. That's why the company has told investors U.S. insulin margins will struggle. The U.S. FTC is currently investigating PBM rebating practices and has stated that rebates paid in order to exclude less costly products may actually be illegal, although it hasn't formally taken any enforcement action (such as with a lawsuit) until it's PBM study is officially finished.

So I shared with Novo Nordisk a few carefully composed Tweets when one of their online chats had just 16 minutes remaining. I never thought much would happen with it. But, I did it anyway.

Below is a "rolled-up" version of my Tweets for convenience of reading them all in the same place. I rolled-up my response on the thread at https://threadreaderapp.com/thread/1573049827528773636.html .

Then, about one week later, I re-visited Novo Nordisk Pharma, Inc.'s (NNPI) website at https://www.nnpi.com/ to see if any other products were included (I check it periodically), and I noticed some things which were not there the last time I visited the site: The inclusion of Insulin Degludec Injection 100 U/mL (as well as another for 200 U/mL, which is a U-200 version of the basal insulin which contains twice as much insulin in each unit and is geared mainly at the insulin-resistant Type 2 diabetes patient population).

As it turns out, the Federal government's National Institutes of Health (NIH) maintains a website called DailyMed https://dailymed.nlm.nih.gov/dailymed/ where images of packages from FDA-approved drugs from each manufacturer are on file. I looked up the newest unbranded products to see what we can expect them to look like; I've included them here for my readers. Note that the UPC bar code hasn't been assigned yet so that information is missing, but the basic package designs are ready to go. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

To visit DailyMed's page on the newest unbranded Novo Nordisk insulins, go to https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1be283d-4b1d-4996-b2a7-4488dbff3037 for the images and other basic info. Neither unbranded products were on the NNPI website previously. The image of the package also contains the FDA NDC numbers which may be relevant for patients going into a pharmacy trying to order the unbranded products.

In fact, until now, Novo Nordisk Pharma, Inc. only sold older, out-of-patent products which had identical unbranded versions on the market, which I considered a half-hearted commitment to the U.S. affordability considering that Novo Nordisk is among the biggest perpetrators of the underlying market dysfunction by paying the BIGGEST rebates to PBM's to get its products on exclusive formulary placement. By the company's last disclosure, Novo Nordisk said it was paying 74% of U.S. gross sales to PBM's as rebates.

Although the company did not introduce an unbranded version of Fiasp in the U.S. (yet), but I believe the company will ultimately be forced to do so when it eventually "retires" Novolog and stops selling the product. That is likely to happen before too long if history provides any evidence. That's practically a guarantee with like a half-dozen biosimilar versions of Novolog from rival companies currently pending FDA approval, so I suspect that it's really a matter of when, rather than if it will happen.

Biosimilars of aspart are now in development from Biocon, Lannett, Amphastar, Sandoz, and Civica. And, those are just the ones I actually know about! Each is in various stages of development.

Curiously, Novo Nordisk's first "Lantus killer" known as Levemir (insulin detemir) was not chosen as the next product to be unbranded. That could have happened if the company wasn't really serious. The reasons there are no unbranded Levemir is likely due to the fact that Levemir has already lost U.S. patent protection, hence there's far less which the company can really do to prevent any biosimilars of that insulin product for those interested in copying them. However, Levemir has never really been a best-selling product in the U.S., hence Novo Nordisk didn't bother with an unbranded version of that product.

While I was thrilled that Novo Nordisk responded (indirectly) with a new, unbranded insulin which will soon become available in the U.S., it doesn't appear as if these were considered before now. The company could also have introduced an unbranded GLP-1 inhibitor products (although none of those are not on the WHO's "essential medicines" list), but I suspect that the company's recent supply-chain problems with those products likely explains the main reason it has not done unbranded versions any of those ... yet.

On that front, along with at least four or five biosimilars of aspart now in development from Biocon, Lannett, Amphastar, Sandoz and Civica, a number of biosimilar-manufacturers now also have versions of liraglutide (sold under such names as Ozempic, Trulicity, Wegovy, Rybelsus, and Saxenda) currently in development (likely concluding the clinical trials needed to commercialize them), so those could likely face new biosimilar competition in the U.S. before long too.

Lilly has a competing GLP-1 product to Novo Nordisk's newer iterations of Victoza on the market called Trulicity (dulaglutide) and a new one called Mounjaro (tirzepatide), but those products still face rebate walls Novo Nordisk has erected around those its blockbuster GLP-1 inhibitor products which now generate a vast majority of the company's U.S. revenues these days.

However, as I said previously, GLP-1 products are not currently on the World Health Organization's list of "essential medicines" whereas insulin IS on the "essential medicines" list. Hence, I'm pleased we may soon see a new, unbranded version of Novo Nordisk's Tresiba on the U.S. market. That could bring affordable access of that product to a much-wider U.S. audience. Just remember, the prices for the unbranded insulin is likely to be even cheaper using a coupon from GoodRx, SingleCare or any number of other coupon-generating websites/apps. Check them all and use them to buy the insulin (bypassing insurance) for the lowest price possible.