South Korea-Based Undbio Co., Ltd. + Proprietary Insulin; Maybe Biosimilars (someday)
On April 13, 2023, a South Korean biopharmaceutical company known as Undbio Co., Ltd.http://undbio.com/eng/ signed a lease with West Virginia University to build what it refers to as an insulin " manufacturing facility " in the city of Morgantown, WV (seehttps://www.wvgazettemail.com/business/undbio-planning-insulin-facility-in-morgantown/article_6b986775-6a2e-5ce5-b312-c423d79cbda2.html for more information). In all likelihood, that will be for what pharma refers to as a " fill& finish " facility, rather than one where temperature-controlled bioreactors are located.Meanwhile, a nonprofit drug company known as Civica, ...
Source: Scott's Web Log - April 24, 2023 Category: Endocrinology Tags: 2023 morgantown west virginia wv mylan biosimilar insulin undbio Source Type: blogs

BusinessWeek Says " Why Cheaper Insulin Today Risks Higher Costs Later " . We should want that!
On April 4, 2023,Bloomberg BusinessWeek magazine published an article entitled " Why Cheaper Insulin Today Risks Higher Costs Later " (seehttps://www.bloomberg.com/news/articles/2023-04-04/cheaper-insulin-from-lilly-and-sanofi-risks-raising-costs-later for the article). Unfortunately, Americans have grown much too accustomed to seeing prescription drug prices being artificially manipulated from behind-the-scenes by entities who rig the system to line their own pockets that today, we instinctively view higher prices in the future as a direct assault. Don ' t play that game!But if the market was working properly to begi...
Source: Scott's Web Log - April 7, 2023 Category: Endocrinology Tags: glucose responsive insulin 2023 Amphastar Biocon bloomberg BusinessWeek Civica insulin prices Lannett Sandoz the Business of Diabetes Source Type: blogs

The Insulin-PBM Rebate Kickback Scheme Appears to Be Coming to an End
Last year, on March 3, 2022, in what I believe was a fantastic accomplishment relatively early in Aaron Kowalski ' s tenure as CEO, the JDRF and Civica, Inc. (via the company ' s CivicaScript operating unit) jointly announced Civica ' s intention to commercialize biosimilars of the three bestselling insulin analogues at an affordable price of $30/vial or $55/box of five insulin pens. The Civica press release can be seen athttps://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ and a concurrent press release from JDRF can be seen athttps://www.prnewswire.com/news-rel...
Source: Scott's Web Log - March 14, 2023 Category: Endocrinology Tags: Eli Lilly and Company 2023 Civica CivicaRx CivicaScript drug prices FTC insulin insulin prices JDRF Novo Nordisk Novo Nordisk Pharma Source Type: blogs

The Insulin-PBM Rebate Kickback Scheme Appears to Coming to an End
Last year, on March 3, 2022, in what I believe was a fantastic accomplishment relatively early in Aaron Kowalski ' s tenure as CEO, the JDRF and Civica, Inc. (via the company ' s CivicaScript operating unit) jointly announced Civica ' s intention to commercialize biosimilars of the three bestselling insulin analogues at an affordable price of $30/vial or $55/box of five insulin pens. The Civica press release can be seen athttps://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ and a concurrent press release from JDRF can be seen athttps://www.prnewswire.com/news-rel...
Source: Scott's Web Log - March 14, 2023 Category: Endocrinology Tags: Eli Lilly and Company 2023 Civica CivicaRx CivicaScript drug prices FTC insulin insulin prices JDRF Novo Nordisk Novo Nordisk Pharma Source Type: blogs

Podcast Episode Recommendation: Politico Pulse Check - Can Mark Cuban disrupt prescription drugs?
Next up on my podcast episode recommendations. Today ' s recommended podcast comes fromPolitico, which is a media outlet that has a podcast called "Pulse Check" . Politico describes its Pulse Check podcast this way: " Politico Pulse Check delivers the latest news in healthcare with sharp policy analysis and a dose of real-world perspective " . In other words, the " Pulse Check " podcast is about healthcare and health care policy emanating from Washington, DC.On December 20, 2022, Politico Plus Check interviewed Mark Cuban about his cash-payCost Plus Drug Company. Before I get to the episode itself, I must acknowledge that ...
Source: Scott's Web Log - January 10, 2023 Category: Endocrinology Tags: 2023 Costco mark cuban politico pulse check podcast Source Type: blogs

Podcast Recommendation: Selected Episides of Diabetes Connections with Stacey Simms
So, my next podcast recommendation is for two specific episodes ofDiabetes 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 athttps://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ or the concurrent JDRF press release athttps://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html). Many people subscribe to Diabetes Connections, although I ' m s...
Source: Scott's Web Log - January 9, 2023 Category: Endocrinology Tags: 2023 Aaron Kowalski Civica Civica Rx CivicaRx GeneSys Biologics Ned McCoy Stacey Simms Source Type: blogs

Mark Cuban CostPlus Drug Company Is Distributing Roche Accu-Chek Testing Supplies
Taking a bit of a break from my recent podcast recommendations, but kind of an extension of the previous one about theMark Cuban CostPlus Drug Company, on October 11, 2022, Mark Cuban ' s startup known as the Mark Cuban CostPlus Drug Company ( " MCCPDC " , in different notices shared on Twitter, LinkedIn, Facebook, etc.) announced a partnership with Roche Diabetes Care to bring CostPlus Drugs patients to buy Accu-Chek testing supplies through them at a lower price.  Thecost of buying Accu-Chek test strips from CostPlus is $16.79 for a quantity of 50 test strips. That works out to a cost of $0.34 per strip. Price-...
Source: Scott's Web Log - October 23, 2022 Category: Endocrinology Tags: 2022 Accu-Chek cash price costplus drug company mark cuban Roche Source Type: blogs

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 prese...
Source: Scott's Web Log - September 29, 2022 Category: Endocrinology Tags: authorized generic insulin analogs 2022 authorized generics Inc. Novo Nordisk Pharma unbranded insulin Source Type: blogs

More Insulin Biosimilars Are Forthcoming; The Market Outlook for Them
During the past few weeks, in both SEC-mandated (for publicly-held companies) earnings reports and investor presentations, plus in the business news and pharmaceutical industry trade press, we received several important, relevant updates on not one, but on FOUR insulin biosimilars currently in development from two different companies. We also know that in addition to them, insulin biosimilars are in development from at least three additional companies, plus as the " innovators " , the traditional " Big Three " insulin-makers of Lilly, Novo Nordisk and Sanofi continue making their bestsellers (for the time being, anyway).&n...
Source: Scott's Web Log - September 12, 2022 Category: Endocrinology Tags: 2022 Biosimilar Biosomilars generic insulin Source Type: blogs

Novartis To Spin-Off Sandoz as Stand-Alone, Public Company
  My readers may recall that I disclosed (see my post athttps://blog.sstrumello.com/2022/07/novartis-sandoz-is-back-in-insulin.html for details) some information buried in Novartis ' July 20, 2022 quarterly earnings release, when buried on page 21 of the company ' s 64-page Q2& half-year 2022 financial statement, when we finally learned that the company ' s planned insulin biosimilars first announced in late 2018 were still very much in development. In fact, the Gan& Lee-manufactured insulin glargine U-100, insulin aspart U-100 and insulin lispro U-100 bisimilars were indeed still happening and may actual...
Source: Scott's Web Log - August 27, 2022 Category: Endocrinology Tags: 2022 Biosimilar biosimilars Gan & Lee insulin Novartis Sandoz Source Type: blogs

Novartis' Sandoz Is Back In The Insulin Biosims Market. Can It Succeed?
Back in December 2018, the Sandoz division of Swiss pharmaceutical giant Novartis announced (see the full announcementHERE) " Sandoz enters into commercialization and supply agreement for insulin biosimilars " . It also revealed that Sandoz had entered a " commercialization and supply agreement with Gan& Lee " which it added was " a leading insulin supplier headquartered in China with more than 20 years ' experience in insulins and production capacity with attractive cost of goods sold (COGS) structures " .Few Americans have ever heard of Gan& Lee, although this year, at the American Diabetes Association ' s 82nd S...
Source: Scott's Web Log - July 22, 2022 Category: Endocrinology Tags: insulin analogs 2022 Biosimilar biosimilars generics insulin analogues Novartis Sandoz Source Type: blogs

CivicaScript Signs Navitus as Partner; Costco Pharmacies Will Sell Civica Insulin Biosims
$30/vial Could Become The New Normal in 2024My readers may recall that on March 3, 2022, I blogged about concurrent press releases from both Civica, Inc. and the JDRF (see my coverageHERE for original news, followed by more detailed analysis on how it was poised to disrupt the PBM kickback schemeHERE) that its CivicaScripts operating unit plans to enter the U.S. market for insulin biosimilars starting first with the basal insulin analogue insulin glargine, followed by biosimilars of lispro and aspart, which is expected to happen in 2024 assuming it encounters no regulatory delays.The original aim of starting with glargine ...
Source: Scott's Web Log - July 19, 2022 Category: Endocrinology Tags: 2022 Biosimilar biosimilars Civica Civica Rx CivicaRx Costco FDA insulin PBM Source Type: blogs

Sanofi Joins The Ranks of $35/vial Insulin, Adds New Unbranded Insulin to Product Lineup
Yesterday, Sanofi U.S. made an announcement: Effective on July 1, 2022, the company will lower out-of-pocket cost of insulin for uninsured patients and expand access in underserved communities (in reality, the lower prices are available to anyone including those who have insurance deductibles to satisfy). The press release can be viewed athttps://www.news.sanofi.us/2022-06-29-Sanofi-to-lower-out-of-pocket-cost-of-insulin-for-uninsured-patients-and-expand-access-in-underserved-communities.Sanofi has been a laggard relative to its rivals Lilly and Novo Nordisk. For example, in 2019, both Lilly and Novo Nordisk each announced...
Source: Scott's Web Log - July 1, 2022 Category: Endocrinology Tags: Sanofi Aventis Sanofi-Aventis 2022 drug prices Euro API insulin insulin prices Source Type: blogs

How the Civica Insulin Announcement Could Be Disruptive to the PBM Kickback Scheme
Yours truly has written an article. I have given some more serious thought to theCivica insulin announcement made on March 3, 2022 (my article has a link to the original press release) and I think it could be very disruptive to what I have dubbed the " PBM Kickback Scheme " . You can read my assessment below, or athttps://www.slideshare.net/ScottStrumello/civica-insulin-assessment.Ironically, this month ' sNew England Journal of Medicine also has a very interesting (and similar) analysis of the exact same topic (the Civica insulin announcement) in its " Perspective " section in an article entitled " A Radical Treatment for...
Source: Scott's Web Log - June 10, 2022 Category: Endocrinology Tags: 2022 Biocon Biosimilar biosimilars Civica Civica Rx CivicaRx insulin Semglee Viatris Source Type: blogs

How The PBM Insulin Scheme Is Poised to Be Disrupted by Civica Rx
So, with this week ' s news focused on other areas (like the Supreme Court), I thought it might be appropriate to focus on something which is still very broken, yet seems poised to be resolved by good old fashioned market forces: insulin prices.The U.S. " market " for insulin is bedeviled by the same problem that causes all U.S. prescription drug prices to be so high: Pharmacy Benefit Managers ( " PBM ' s " ) are manipulating prescription drug discounting behind-the-scenes in order to enrich themselves at everyone else ' s expense. Most discounts PBM ' s collect come in the form of cash rebates, which are paid by pharmaceu...
Source: Scott's Web Log - May 4, 2022 Category: Endocrinology Tags: 2022 biogenerics Biosimilar biosimilars Civica Rx CivicaRx insulin insulin analogs Lilly Novo Nordisk PBM Sanofi Source Type: blogs