Monday, January 09, 2023

Podcast Recommendation: Selected Episides of Diabetes Connections with Stacey Simms

So, my next podcast recommendation is for two specific episodes of Diabetes Connections with Stacey Simms, and more specifically two in which she discusses the Civica insulin announcement which was first announced on March 3, 2022 (see the original Civica press release at or the concurrent JDRF press release at 

Many people subscribe to Diabetes Connections, although I'm stopping short of recommending a subscription to the podcast itself. The reason is because Stacey Simms is a diabetes mom, but that alone isn't a reason for recommending subscribing (it's not a reason to avoid it, either).

But if I'm being completely honest, over the years I've learned to listen to podcasts and/or read blog postings from diabetes parents very selectively. If I didn't, I think I would drive myself insane. I'm a person who has lived with Type 1 diabetes for close to a half-century (I'll earn my Joslin 50-year medal in 2026), and I'm long past the learning curve or shock of living life with T1D as many parents of newly diagnosed children are. I have to listen to podcasts or read blog posts from mommies and daddies of kids with T1D only when time permits, and only when the topic they're covering is of personal interest.  My focus is ordinarily from a business perspective, and not everyone would necessarily ask the same questions I'd ask. 

That's OK.

Stacey Simms is not the person living with Type 1 diabetes herself, her son Benny is. Parents' concerns are often very different from an adult person with diabetes. I can give kudos to Stacey because some of the episodes and her guests have been fantastic, while other episodes are completely disposable IMHO. The great thing with podcasts is you don't have to listen to every episode unless you like the podcaster or the guest.

Still, there were a few episodes which I recommend on Diabetes Connections with Stacey Simms. Specifically, was her coverage of the Civica insulin announcement. The episodes are below:

In particular, two episodes on the Civica insulin announcement were worth catching. First up was the interview with JDRF CEO Aaron Kowalski just a few days after the Civica insulin announcement was made. That podcast can be listened to below, or by visiting Beware there are some details in the actual press release which are quite relevant, but might be overlooked unless you are someone who follows the biosimilars industry as I do. More on that in a second.

The follow-up was an interview Stacey Simms did with Ned McCoy, who is Civica's Chief Operating Officer. The podcast can be listened to below, or by visiting

Still, both JDRF's Aaron Kowalski and Civica's Ned McCoy seem to casually dance around the reality that Civica isn't technically manufacturing the insulin biosimilars at all. 

Instead, the actual bioreactors for Civica insulins will be located offshore in a co-development partner located in Hyderabad, India named GeneSys Biologics. The insulin "Active Pharmaceutical Ingredient" or "API" of the insulin biosimilars will actually be made there, then shipped to the U.S., and Civica will basically package it into vials and/or insulin pens in a "fill & finish" facility in Petersburg, VA just south of the state capital of Richmond. That's not really "manufacturing" the insulin in my view. Still, pharma considers that practice ordinary (to rely on offshore manufacturing to fatten their own bottom lines), they treat it as if it were completely normal. In biosimilars, nearly every company uses an offshore partner (in India, China, Malaysia or elsehere), only the margins are most typically used to pay PBM's legally-exempted, cash "rebate" kickbacks. The difference is that instead of the margins being used to fatten pharma's bottom line or pay multi-billion dollar rebate kickbacks to PBM's to secure exclusive drug formulary placement, instead, Civica will use the margins to reduce patient prices.

That part is very unique, and Civica is uniquely positioned to make that cost-plus insulin a reality. No doubt, that will put additional pressure on Big Three branded insulin-makers to either cut their prices (Lilly has already done so on unbranded Humalog), or stop making the patent-expired insulin varieties leaving only the patented product in their portfolio (I'm willing to bet we see Novo Nordisk "retire" Novolog/Aspart when the half-dozen or so biosimilars of that hit the market around 2024; expect them from Biocon, Sandoz, Lannett, Amphastar and Civica). The only difference is this time, Novo Nordisk won't be able to force patients to use its newest insulin unless the price is right; the alternative will be that patients can simply use biosimilars made by nearly a half-dozen other companies instead.

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