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
UHC's August 2022 Optum Insulin Announcement: More PR Fluff? We Don't Really Know.
On August 1, 2022, United Healthcare Group ' s PBM business known as Optum made a press release of its own related to insulin:Optum to Offer Lower-Cost Insulin for Uninsured People Living With Diabetes on Optum Store https://www.businesswire.com/news/home/20220801005282/en/Optum-to-Offer-Lower-Cost-Insulin-for-Uninsured-People-Living-With-Diabetes-on-Optum-Store/This comes on the heels of United Healthcare ' s own goodwill-generating PR move made on July 15, 2022 which was as follows:UnitedHealthcare To Eliminate Out-of-Pocket Costs on Several Prescription Drugs, Including Insulin, for Eligible Membershttps://www.busi...
Source: Scott's Web Log - August 4, 2022 Category: Endocrinology Tags: authorized generic UnitedHealthCare 2022 insulin insulin prices OptumRx PBM United Healthcare Source Type: blogs
FDA Moves to Expand NDC Numbering to Accommodate Rapid Rise in " Authorized Generic " Drugs
On July 22, 2022, the U.S. Food and Drug Administration ( " FDA " ) announced a proposed new rule (seehttps://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-drug-label-barcode-requirements for the announcement in theFederal Register, or the FDA ' s own page on the announcement athttps://www.fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format, effectively Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No.FDA-2021-N-1351), that is intended to minimize the impact of the FDA running out of ten-digit n...
Source: Scott's Web Log - August 2, 2022 Category: Endocrinology Tags: authorized generic 2022 authorized generics FDA insulin NDC 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
The Business of Diabetes: 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
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
How to Navigate Life with a Chronic Disease Like T1D and High-Deductible Insurance - Redux
Last February (2021), I wrote a blog post called " How to Navigate Life with a Chronic Disease Like T1D and High-Deductible Insurance Plans " (read my post athttps://blog.sstrumello.com/2021/02/how-to-navigate-life-with-chronic.html for details).I still stand by all of the recommendations I made in that blog post because I actually used (and still use some) the methods described effectively and saved a lot of money by doing so. But times change, and sometimes strategies need to evolve with changes that happen in the world around us.Intro of " Authorized Generic " Insulins, plus Branded/Unbranded BiosimilarsFor example, in ...
Source: Scott's Web Log - April 7, 2022 Category: Endocrinology Tags: 2022 high-deductible insurance plans insulin Source Type: blogs
My Recent Podcast on " The Diabetes Way "
A frequent complaint about U.S. prescription drug prices is it is difficult to explain WHY the prices here are so high. A frequent pharma answer to the question WHY is this happening is " it ' s complicated " . They aren ' t kidding. it IS complicated. But today, there are tools on the internet which can help many people navigate the dysfunctional U.S. system without being taken to the cleaners. I recently did a podcast about that which might be worth listening to. But it ' s helpful to understand how I became the guy the podcasters wanted to interview about the subject.Back in September 2021, I was invited as a guest to s...
Source: Scott's Web Log - March 23, 2022 Category: Endocrinology Tags: David Kliff 2022 Amber Clour coupons podcast prescriptions rebates Rx The Diabetes Way Source Type: blogs
Civica Rx: We're Entering the U.S. Insulin Biosimilar Business!
This morning, I woke up and unplugged my phone from its charger, and went to close Twitter (which I forgot to close last night before I went to bed) and at the top was a press release from Civica Rx. The press release is here: Civica to Manufacture and Distribute Affordable Insulinhttp://dlvr.it/SL0QZV The news was greeted as a welcome development by JDRF, Beyond Type 1 and the Helmsley Charitable Trust to name a few. The ADA said nothing formally about it as of 10:00 AM. In essence, Civica Rx says it plans to sell biosimilar versions of Lantus, Humalog and Novolog. As usual, there ' s a lot of details unpack her...
Source: Scott's Web Log - March 3, 2022 Category: Endocrinology Tags: 2022 Biocon Biosimilar biosimilars Civica Rx CivicaRx insulin Viatris Source Type: blogs
Welldyne's WellCardRx Discount Card/App: Another PBM-Powered Discount Card
In several recent posts during the past few years, I ' ve addressed the emergence of prescription drug discount cards and apps. Perhaps the most notable post on that can be seenHERE.Much of that began with the company known asGoodRx Holdings, Inc., but a downside to GoodRx is because it only has access to a single formulary (most PBM ' s typically a high-price/high-rebate formulary which benefits the PBM, and others demanded by big clients which tend to favor lower cost generic drugs) offered by each PBM it does business with, that also means it may not have access to the other formularies which mainly preference generic d...
Source: Scott's Web Log - February 7, 2022 Category: Endocrinology Tags: 2022 coupon-generating websites apps coupons Discount Card GoodRx PBM prescriptions Source Type: blogs
Why Biosimilar Makers (incl. Insulin) Must Sell 2 Versions of their Copy-Cat Meds in USA
Recall that Adam Fein, who writes the Drug Channels blog, recently documented (seeHERE for details) that Viatris (fka Mylan) and its biotech co-development partner Biocon, recently revealed that in spite of earning the FDA " interchangeable " designation for the insulin biosimilar of Sanofi ' s Lantus for the product Viatris branded Semglee that they would be using prescription drug rebates needed to bribe, errr ... secure PBM formulary placement. They willoffer both a branded and un-branded version ... of a biosimilar. That ' s weird. FiercePharma documented the curious necessity for biosimilar makers to sell two ver...
Source: Scott's Web Log - November 21, 2021 Category: Endocrinology Tags: Biocon coupon-generating websites apps formulary PBM Viatris Walgreens Source Type: blogs
Some Key EASD News for T1D
This week, the European rival to the ADA Scientific Sessions known as EASD (which stands for the European Association for the Study of Diabetes) held its annual meeting, which was the organization ' s 57th Annual Meeting and it took place virtually (much like the ADA Scientific Sessions did this year) due to COVID-19. EASD was held from September 27, 2021 to October 1, 2021. In recent years, neither the ADA Scientific Sessions not the EASD Meetings have yielded many surprise findings or previously unknown product launches.My short summary is that Novo Nordisk is finally getting on the " smart pen " cap bandwagon, while riv...
Source: Scott's Web Log - October 1, 2021 Category: Endocrinology Tags: 2021 Bigfoot Unity Companion Medical EASD FTC insulin prices Lilly Medtronic diabetes Novo Nordisk rebate reform Smart Pen Caps Smart Pens Source Type: blogs
