Lilly's Carelessness in Discontinuing 3 mL vials of Humalog Causes Shortages in 10 mL vials of Humalog + Unbranded Lispro
Last week, the JDRF shared newshttps://x.com/JDRF/status/1770848177354137650 in a series of three Tweets about how Eli Lilly& Company, Inc. was reporting that 10 mL vials of Humalog and the company ' s identical, unbranded (meaning Lilly sells it using the generic drug name rather than brand-name Humalog) version of Humalog known as Lilly Insulin Lispro Injection could be facing temporary lack of availability in selected locations around the country. Lilly tried to reassure everyone that it was only a temporary issue. But while Lilly complains it cannot keep up with demand for Mounjaro/Zepbound, it is having its own su...
Source: Scott's Web Log - April 9, 2024 Category: Endocrinology Tags: Eli Lilly and Company 2024 Humalog lispro vials Source Type: blogs

Patient Advocates Argue Exercising Bayh-Dole " March-In " Rights Reasonable to Ensure Ongoing Supply of an Insulin Novo Nordisk Intends to Discontinue
Back in 2016 (when President Obama was still in office), the trade group known as the Pharmaceutical Research and Manufacturers of America (better known by the acronym PhRMA) claimed in an organization-published white paper (seehttps://web.archive.org/web/20161022175500/https://phrma.org/sites/default/files/pdf/bayh-dole-act-white-paper-summary.pdf for an archived copy of that paper from PhRMA; note that it has since been removed from PhRMA ' s website, hence I found a copy on the Internet Archive) that championed the Bayh-Dole Act of 1980. Understand that what PhRMA really wants to prevent a particular provision...
Source: Scott's Web Log - February 11, 2024 Category: Endocrinology Tags: march-in rights 2024 Alliance to Protect Insulin Choice APIC Bayh-Dole insulin detemir Levemir Novo Nordisk Source Type: blogs

The Business Case for a Biosimilar Company to Bring a Copy of Levemir to Market
My readers may recall that in November 2023, I blogged that Novo Nordisk announced it plans to retire (stop making) its first " Lantus killer " known as Levemir (insulin detemir injection) in the U.S. in 2024 (catch my post at https://blog.sstrumello.com/2023/11/novo-nordisk-to-discontinue-levemir-in.html for more). At the time I learned of the announcement, I was on vacation in Amsterdam, so I just made a note of the development and blogged about it a few weeks later upon my return.Like other patients my age, I have endured the company ' s previous insulin " retirements " . Novo Nordisk ' s time-frame for withdr...
Source: Scott's Web Log - January 25, 2024 Category: Endocrinology Tags: 2024 Biosimilar Levemir Novo Nordisk PBM Source Type: blogs

Ginger Vieira – Exercise with Type 1 Diabetes
In conclusion, Ginger Vieira’s book, Exercise with Type 1 Diabetes (affiliate link), is a must-read for anyone with diabetes who wants to incorporate exercise into their daily routine. Ginger’s expertise and personal experiences make this book a valuable resource for understanding the impact of exercise on blood sugar levels and managing diabetes effectively. With practical tips and a supportive approach, Ginger empowers readers to take control of their health and enjoy the benefits of exercise. Don’t miss out on this concise and informative guide! ...
Source: Scott's Diabetes Blog - December 20, 2023 Category: Endocrinology Authors: Scott K. Johnson Tags: Blog Posts Source Type: blogs

Your Insulin of the Future Could Be " Made in China " if Big PBMs Have a Say in the Matter
Back on June 16, 2022, I published an article on LinkedIn entitled "How the Civica Insulin Announcement May Be Disruptive to the PBM Kickback Scheme" (see the article athttps://www.linkedin.com/pulse/how-civica-insulin-announcement-may-disruptive-pbm-scheme-strumello/ if you wish to read it) which predicted that a growing number of insulin biosimilars whose active pharmaceutical ingredients (API ' s) are cultured in offshore laboratories are forecast to hit the U.S. market in the next few years. According to the FDA and the individual companies whom I also follow on LinkedIn, the U.S. Food and Drug Administration (FDA) typ...
Source: Scott's Web Log - October 15, 2023 Category: Endocrinology Tags: 2023 Congress insulin insulin prices lawmakers PBM Pharmacy Benefit Managers Source Type: blogs

Another Three Biosimilar Insulins Planned from Meitheal Pharmaceuticals, Inc.
On September 21, 2023, Chicago-basedMeitheal Pharmaceuticals, Inc. (which is a subsidiary of a Chinese parent company named Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.) announced an exclusive commercial licensing agreement with a different Chinese company known asTonghua Dongbao Pharmaceutical Co. Ltd. with intent to sell three insulin biosimilars in the U.S. market.     The company press release can be seen athttps://www.meithealpharma.com/news/61 while the pharmaceutical industry trade press covered the story athttps://www.thepharmaletter.com/article/licensing-deal-to-bring-three-new...
Source: Scott's Web Log - September 30, 2023 Category: Endocrinology Tags: 2023 Biosimilar insulin Meitheal Pharmaceuticals Source Type: blogs

Podcast Episode Recommendation for Deconstructed: Medicare Drug Pricing Negotiations Advance
So, today I am going to share a podcast episode which provides an interesting history of how Medicare ended up being unable to negotiate prescription drug prices which, on its face, seems like it SHOULD make no sense, but somehow price negotiations never happened and the reasons were really absurd. Naturally, since the list of the first 10 drugs to get Medicare price negotiations was published, there has also been considerable discussion of insulin prices which is the poster-child for how broken the prescription drug market is, and even more interestingly was how, included in the first round of Medicare price negotiat...
Source: Scott's Web Log - September 1, 2023 Category: Endocrinology Tags: 2023 Biden Centers for Medicare & Medicaid Services Joe Biden Part D price negotiations Source Type: blogs

Why Amazon Pharmacy's Recent Insulin Move is Helpful, But Not Groundbreaking
On August 15, 2023, Amazon Pharmacy (fka PillPack) announced (seehttps://www.aboutamazon.com/news/retail/amazon-pharmacy-insulin-coupons/ for the announcement) that it would begin automatically applying various manufacturer coupons to more than 15 common insulins and diabetes devices (including Dexcom, which offers a coupon for up to $200 per month athttps://www.dexcom.com/en-us/savings-center-cgm-without-insurance/ even without insurance). So far, no coupons from Abbott on Freestyle Libre 3 sensors, but the longer wear-time of 14-days means those cost about one-third less than Dexcom ' s 10-day Some products, such as bloo...
Source: Scott's Web Log - August 22, 2023 Category: Endocrinology Tags: 2023 Amazon Amazon Pharmacy coupons insulin prices Source Type: blogs

Podcast Episode Recommendation: Healthy Dose of Dialogue Episode 31 " A Dose of Prescription Drug Disruption "
Today, I am recommending a podcast episode worth listening to. Specifically, it is an episode from June 15, 2022 of the podcast known as " Healthy Dose of Dialogue " which describes its mission to " gather the brightest minds in healthcare to share their unique perspectives on transformative marketplace trends, industry insights, and their vision for the future " .This particular episode (EP31: " A Dose of Prescription Drug Disruption " ) is an interview with the President of CivicaScript LLC, which in case you weren ' t aware of it, is an affiliated business unit of the nonprofit drug company Civica, Inc. The president of...
Source: Scott's Web Log - August 9, 2023 Category: Endocrinology Tags: 2023 Biosimilar Civica Civica Rx CivicaRx CivicaScript insulin podcast podcast episode recommendations ypsomed Source Type: blogs

What happens when Rx price bubbles (such as on insulin) burst?
In the first half of 2023, Americans witnessed evidence of a rather fundamental shift in the manner pharma had traditionally opted to commercialize selected prescription drugs. Specifically, in March 2023,Lilly,Novo Nordisk andSanofi each announced they planned to slash insulin list prices for insulin. To do so, they would disintermediate PBMs from the transaction and " opt out " of the PBM commercialization channel.The decision wasn ' t really all that difficult; for years branded insulin-makers had been complaining that PBMs and other drug distribution system entities had been gobbling up an ever-larger share of their re...
Source: Scott's Web Log - June 19, 2023 Category: Endocrinology Tags: 2023 Source Type: blogs

Sandoz/Gan & Lee Now Has Applications for Glargine, Lispro and Aspart Insulin Biosimilars on File with FDA, Expect them to come to market in early 2024.
Five years ago, back on December 19, 2018, Swiss pharmaceutical giant Novartis Pharma AG quietly issued a press release (seehttps://www.globenewswire.com/news-release/2018/12/19/1669194/0/en/Sandoz-enters-into-commercialization-and-supply-agreement-for-insulin-biosimilars-anticipating-growing-demand-as-diabetes-burden-rises.html for the release itself) on behalf of the company ' s business unit known as Sandoz. Specifically, Novartis said that its Sandoz generics unit planned to introduce biosimilars, or near-copy, versions of Sanofi ' s Lantus (glargine), Novo Nordisk ' s Novolog (aspart), and Eli Lilly ' s Humalog (lispr...
Source: Scott's Web Log - June 16, 2023 Category: Endocrinology Tags: 2023 Biosimilar biosimilars Gan & Lee insulin Sandoz Source Type: blogs

Podcast Episode Recommendation: Dear Diabetes Podcast with hostess Rene é Rayles Episode 7
 The Dear Diabetes Podcast with hostess Rene é Rayles is a relatively new podcast covering the subject of diabetes; it began quite recently on March 29, 2023. However, Reneé Rayles recently interviewed Civica, Inc. ' s current CEO Ned McCoy.  Recall that on June 1, 2023, Ned McCoy succeeded Martin VanTrieste as Civica ' s President and CEO (see the press release athttps://www.businesswire.com/news/home/20220524005169/en/Civica-Announces-Leadership-Transition for details). She spoke with Mr. McCoy about the company ' s affordable insulin biosimilar effort, which is proceeding according to planCivica has released...
Source: Scott's Web Log - June 2, 2023 Category: Endocrinology Tags: 2023 Civica CivicaRx CivicaScript Dear Diabetes Podcast podcast episode recommendations Rene é Rayles Source Type: blogs

Humira Biosimilar Gross-to-Net Pricing Bubble Was Preceded by the Same Pricing Bubble Burst for Insulin Just Months Ago
Today ' s post is not about diabetes per se, although there IS a diabetes connection. But this morning, the big news was that a biosimilar of Abbvie ' s blockbuster anti-inflammatory biologic Humira will be sold byMark Cuban Cost Plus Drug Company (see the press release athttps://www.globenewswire.com/news-release/2023/06/01/2680351/33333/en/Mark-Cuban-Cost-Plus-Drug-Company-joins-forces-with-Coherus-to-make-YUSIMRY-a-HUMIRA-biosimilar-available-to-patients.html for more) at what amounts to an 85% discount to the innovator drug. Mark Cuban Cost Plus Drug Company announced the Humira biosimilar on social media today. See th...
Source: Scott's Web Log - June 1, 2023 Category: Endocrinology Tags: 2023 Abbvie Biosimilar drug discounts gross-to-net bubble Humira insulin Source Type: blogs

" Endocrine News " Podcast Episode 69: Biosimilar Insulin
The Endocrine Society has several podcasts; one of its podcasts is known by the name of " Endocrine News " . Ordinarily, I ignore most of the Endocrine Society podcasts because: a) they tend to be disproportionately focused on the topic of Type 2 diabetes and treatments for that and b) even when the podcast subject matter includes Type 1 diabetes, I find alternative sources provide considerably more information on the same topics. Partly, it is because the Endocrine Society ' s Endocrine News podcast tends to be only about 10-30 minutes in length which is frequently insufficient to address the topics they aim to addre...
Source: Scott's Web Log - May 6, 2023 Category: Endocrinology Tags: 2023 Biosimilar Biosomilars endocrine news episode insulin irl hirsch podcast podcast episode recommendations the endocrine society Source Type: blogs

Approaching a Half-Century of Life With Type 1 Diabetes (T1D)
On July 24, 2023, I will mark 47 years of having lived with autoimmune Type 1 diabetes (T1D). I was diagnosed as a seven year old, so not quite fifty years ago, but much closer than I ever really anticipated. When I was diagnosed in 1976, no one told me that I should expect horrific complications or that I ' d die young because threats weren ' t part of the conversation; some may have been due to my age. But there was also no such thing as a certified diabetes educator in 1976; instead, pediatric nurses instructed patients on how to give themselves an injection. In fact, scientists had only proven that Type 1 diabetes h...
Source: Scott's Web Log - April 26, 2023 Category: Endocrinology Tags: 2023 50 years half century half-century joslin medal Source Type: blogs