Interchangeable Status Rapidly Boosted Scripts for Insulin Biosimilar

 

• Prescriptions for the insulin glargine biosimilar Semglee increased after it was granted interchangeable status with its reference product, Lantus.
• Increases were seen across retail, mail order, and long-term care pharmacy dispensing channels.
• "Interchangeability may be valuable for inducing increased utilization of biosimilars, which in turn may lead to cost savings and increased patient access," the researchers said.

Prescriptions for insulin glargine-yfgn (Semglee) rapidly increased when its status switched from a standard biosimilar to the first interchangeable insulin biosimilar, an economic evaluation found.

After the biosimilar officially launched with its interchangeable status in November 2021 -- allowing for pharmacy-level substitutions -- there was a discontinuous increase of 47,410 dispensed prescriptions for the generic and brand name forms of the long-acting insulin biosimilar (P=0.001), reported Stephen Murphy, PhD, and Nicholas Holtkamp, PhD, both of HHS in Washington, D.C.

The sharp increase suggests the "interchangeable designation was associated with substantially increased utilization," the pair wrote in JAMA Health Forumopens in a new tab or window. "Semglee and insulin glargine-yfgn's share of the total insulin glargine market matched its dispensing trends, demonstrating that the jump in dispensing was not associated with changes in the market as a whole."

FDA first approvedopens in a new tab or window the biosimilar in June 2020 for the same indications as its reference product, insulin glargine (Lantus) -- type 1 diabetes in kids and adults and type 2 diabetes in adults. According to the biosimilar's developersopens in a new tab or window, it launched "at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market."

Then in July 2021, the agency upgraded Semglee's statusopens in a new tab or window to an interchangeable product. The designation means that there are no clinically meaningful differences between the biosimilar and its reference biologic in terms of safety, purity, and potency, so the two products can be swapped out by pharmacists without a prescriber intervening -- similar to the process with generic drugs.

"The present results illustrate that interchangeability may be valuable for inducing increased utilization of biosimilars, which in turn may lead to cost savings and increased patient access," Murphy and Holtkamp pointed out.

"In the case of insulin glargine, which is primarily distributed through retail pharmacies, this may work through automatic pharmacy substitution or increased physician prescribing if the interchangeability designation generates more trust in the biosimilar," they explained. "Other biosimilars may similarly experience increased utilization if deemed interchangeable, although their experience may vary along a number of dimensions, for instance due to nature of administration, existing competitors, and formulary strategies."

The quick uptake of the interchangeable long-acting insulin product was seen across the board in all three pharmacy dispensing channels:

• Retail: increase of 20,270 prescriptions (P=0.03)
• Mail order: 6,630 (P<0.001)
• Long-term care: 20,520 (P<0.001)

That being said, the jump did coincide with "advantageous" changes in the biosimilar's formulary due to a new higher price/rebate structure that could have impacted dispensing habits, the researchers noted.

But during this transition time, dispensing of prescriptions for insulin glargine-yfgn also increased "despite competing against newly interchangeable Semglee that was advantaged by pharmacy benefit manager formularies -- again suggesting that the interchangeability designation was associated with increases in dispensing," the researchers pointed out.

When broken down by payer, insulin glargine-yfgn adoption grew faster than Semglee and reached higher levels of dispensing in every single period measured after launch for Medicare Part D, Medicaid, and cash channels. In the commercial channel, insulin glargine-yfgn still initially grew substantially faster than Semglee on launch until January 2022, when Semglee dispensing spiked, surpassing insulin glargine-yfgn.

Murphy and Holtkamp used prescription drug data from National Prescription Audit and PayerTrak, two proprietary IQVIA databases, for the analysis. Both databases separately measure brand-name Semglee, biosimilar insulin glargine-yfgn, and the rest of the insulin glargine market. The researchers analyzed data from September 2019 to June 2024.

Only manufacturer prices were available, Murphy and Holtkamp pointed out as a limitation of the study. Also, the researchers weren't able to assess rebates and estimate cost savings due to the increase in utilization of biosimilar insulin glargine.

Disclosures

The study was supported directly by HHS.

Murphy and Holtkamp both reported employment with HHS. No other disclosures were reported.

Primary Source

JAMA Health Forum

Source Reference: opens in a new tab or windowMurphy SJ, Holtkamp NC "Prescription dispensing for insulin glargine after interchangeable biosimilar designation" JAMA Health Forum 2025; DOI: 10.1001/jamahealthforum.2025.0033.

https://www.medpagetoday.com/endocrinology/type1diabetes/115401

AAD survey shows sharp increase in sun damage across the U.S.

 A recent survey of more than 1,000 U.S. adults showed that nearly all Americans believe sun protection is important, with 1 in 4 citing the influence of a dermatologist as the reason. However, Americans have experienced sun damage at increasing rates since 2020, putting themselves at risk for skin cancer.

Ninety-six percent of Americans believe sun protection is important. Despite this, 67% of Americans got tanned or darker skin in 2024, up from 54% in 2020. Additionally, 35% were sunburned, up from 25% in 2020, including nearly 50% of Gen Z and millennials.

In recognition of Skin Cancer Awareness Month (May) and Melanoma Monday® on May 5, the American Academy of Dermatology (AAD) is encouraging the public to practice safe sun to reduce their risk of skin cancer.

Fifty-one-year-old mother of two, Alison Houston echoes the importance of practicing safe sun habits following her own melanoma diagnosis in June 2020. While the deadliest form of skin cancer, melanoma is highly treatable if caught early. Luckily for Alison, board-certified dermatologist Sandra Johnson, MD, FAAD, did just that.

“I have had several moles previously removed, but none had been skin cancer. At my yearly skin check, my dermatologist noticed a new spot that looked suspicious on the right side of my stomach and was removed and examined for signs of cancer. A few days later, the results came back with a diagnosis of melanoma,” said Alison. “With my fair skin, I’ve learned firsthand how important it is to stay protected, and I encourage others to take sun safety seriously.”

Alison’s skin cancer journey has also impacted her family’s relationship with sun protection.

“While I did use sun protection before my diagnosis, I was nowhere near as vigilant as I am now,” said Alison. “My husband and two sons join me in wearing sunscreen daily, and we make sure to never forget a hat and sun protective clothing to cover any exposed area not covered by sunscreen.”

With more than one-third of Americans experiencing sunburn in 2024, it is more important than ever to discuss prevention and early detection of skin cancer. This is particularly important for individuals who put themselves at a greater risk for skin cancer and early aging by tanning indoors or spending extended periods of time in the sun, according to AAD President Susan C. Taylor, MD, FAAD.

“In 2024, one in six Americans felt it was worth looking great now even if it means looking worse later in life with two-thirds of Americans preferring how their skin looks with a tan,” said Dr. Taylor. “Many people don’t realize that the steps they take now to protect themselves from the sun can make a huge difference down the road — do your future self a favor and take action today.”

https://www.aad.org/news/new-survey-shows-sharp-increase-in-sun-damage

80% of Oncologists Cite Insurance as Major Barrier to Timely Cancer Treatment

 The 39th Barometer from Sermo, a fast, frictionless HCP engagement platform providing the healthcare industry with real-time business insights and authentic physician touch points, found that the majority (80%) of surveyed oncologists report that they always, often, or sometimes encounter delays in treatment initiation due to prior authorization requirements. The primary challenges oncology patients face in accessing advanced treatments, as reported by oncologists, include insurance hurdles and the complexities of prior authorization. These challenges are followed by the burden of high out-of-pocket costs and the limited availability of clinical trials.

As Dr. Guy Jones, Radiation Oncologist and Medical Director of Oncology Nevada and Sermo Medical Advisory Board member, explains, “Prior authorizations are a major burden in our field, and across cancer care in general. We’ve been advocating at the state-level here in Nevada for significant changes, such as automatic approvals for cases where authorizations are nearly always historically granted. It’s frustrating to see patients in pain or need urgent treatment delayed by barriers that ultimately serve no clear purpose. This process needs to be streamlined for timely care delivery.”  

Barriers to Accessing Advanced Oncology Treatments:
The barometer found that more than half (54%) of surveyed oncologists always or often refer patients to clinical trials for new treatments. Oncologists are also relying heavily on data from these clinical trials in their decision-making process. The majority (77%) of oncologists believe that clinical trial data is the most influential factor in their decision to adopt a newly approved treatment.

According to a recent Nature analysis, 770 NIH research grants have been terminated as of April 7th, 2025. More than 100 clinical trials funded by the NIH are now at risk of being halted due to the terminations, likely resulting in significant interruptions to patient care.

“The barometer findings underscore the vital role clinical trials play in advancing effective patient treatments, something I hold close to my heart as a cancer survivor,” says Peter Kirk, Sermo CEO and Be Your Possible Founder. “It’s important that the community rallies around raising funds for life-saving medical research. Over the past three years, our Run for Research event has unlocked $850,000 on behalf of Sermo to more than 50 research organizations, with participation from 10,000 individuals globally. Together, we can make a meaningful impact in keeping the teams behind clinical trials innovating.”

While oncologists strive to provide patients access to innovative oncology treatments through clinical trials, significant barriers arise. For 37% of oncologists, strict eligibility criteria pose the greatest challenge. 21% cite the geographic distance to trial sites as the primary obstacle, and 16% point to the limited availability of trials for specific cancers as a major hurdle.

Dr. Jones further emphasizes, “The biggest barrier is often access. If portions of the trial can be conducted closer to home, patients could avoid unnecessary travel. Making these trials more accessible is crucial to improving patient participation.” 

The Future of Oncology Treatment Plans:

• Immunotherapy: 93% of oncologists expect significant or moderate growth in immunotherapy use over the next five years.
• Biomarker Testing: 85% frequently use biomarker testing to guide treatment, but 42% cite long result turnaround times as a major challenge.
• Cancer Vaccines: 68% see cancer vaccines as transformational, though 42% identify limited clinical trial data as a key barrier.
  

How Oncology Teams Want to be Supported by Pharma Companies:
86% of surveyed oncologists reported being very satisfied/somewhat satisfied with the educational and patient support resources provided by pharma companies for oncology treatments. Among APPs who specialize in oncology, this sentiment increased to 94%.

When asked how pharmaceutical companies could better support them, oncologists prioritized expanded financial assistance programs (61%), followed by improved access to clinical trial information (49%) and more patient education materials (45%). While APPs value financial assistance (78%), they also prioritize real-world evidence, data sharing (54%), and better healthcare provider training (54%) as key areas of focus.

This survey was fielded from April 14th-18th, 2025 as the 39th edition of Sermo’s ongoing Barometer study. The survey included 304 global oncologists and advanced care providers. To explore more findings, visit: https://app.sermo.com/barometer 

https://www.sermo.com/press-releases/80-of-oncologists-cite-insurance-as-major-barrier-to-timely-cancer-treatment-sermo-barometer-reveals/

Apple partnering with startup Anthropic on AI-powered coding platform

 Apple is partnering with Amazon-backed startup Anthropic on a new "vibe-coding" software platform that will use artificial intelligence to write, edit, and test code on behalf of programmers, Bloomberg News reported, citing people with knowledge of the matter.

"Vibe coding" refers to a programming method where AI agents generate code, a concept gaining popularity in the AI landscape.

The new AI coding system is an updated version of Apple's programming software, Xcode, and will integrate Anthropic's Claude Sonnet AI model, the report said.

Apple plans to deploy the software internally, with the company still undecided on a public launch, the report added.

Previously, Apple announced an AI-driven coding tool for Xcode named Swift Assist, intended for a 2024 release. However, it was never made available to developers, with some concerns from Apple's engineers about potential slowdowns in app development, Bloomberg added.

Coding assistants are gaining traction in the rapidly evolving AI landscape, with Bloomberg News reporting last month that GenAI pioneer OpenAI is in discussions to buy artificial intelligence-assisted coding tool Windsurf for about $3 billion.

Amid intense competition among major tech firms to dominate the burgeoning generative AI sector, Apple is increasingly partnering with established AI companies and integrating a host of on-device AI features to enhance its offerings.

Apple has been equipping its devices with more powerful chips designed to handle AI tasks, such as summoning OpenAI's ChatGPT to answer user queries, as it seeks to attract customers.

https://www.channelnewsasia.com/business/apple-partnering-startup-anthropic-ai-powered-coding-platform-bloomberg-news-reports-5105766

UTC Bid to Delay Launch of Liquidia’s Yutrepia Shot Down

 A federal judge dismissed United Therapeutics Corp.'s cross-claims against Liquidia Corp. and the US Food and Drug Administration, allowing Liquidia’s lung-disease drug Yutrepia to move forward for a launch as early as this month.

https://news.bloomberglaw.com/ip-law/utc-bid-to-delay-liquidias-yutrepia-launch-shot-down-by-judge

Novo Nordisk shares jump as FDA accepts oral Wegovy application

 Novo Nordisk (NYSE:NVO) shares climbed 5.4% Friday after the U.S. Food and Drug Administration accepted the company’s New Drug Application for an oral version of Wegovy. If approved, the pill formulation would be the first oral GLP-1 treatment for chronic weight management in adults with obesity or overweight conditions.

The submission is based on results from the phase 3 OASIS 4 trial, which studied a 25 mg dose of oral semaglutide in adults without diabetes but with obesity or at least one comorbidity. The 64-week trial supported the company’s push to expand Wegovy’s label beyond its current injectable form.

“We are pleased with the FDA’s acceptance of our submission,” said Anna Windle, Senior Vice President at Novo Nordisk. She added the company looks forward to collaborating with regulators on what could be “a groundbreaking treatment option for obesity.”

The FDA’s final decision is expected in the fourth quarter of 2025. Investors appear optimistic that an oral version of the blockbuster drug could expand adoption and solidify Novo Nordisk’s lead in obesity care.

The announcement follows news that CVS (NYSE:CVS) Caremark will make Wegovy its preferred GLP-1 therapy beginning July 1. The agreement includes enhanced lifestyle support under CVS’s weight management program, broadening access at lower cost.

Meanwhile, key competitor Eli Lilly and Company (NYSE:LLY) continues development of its own oral GLP-1, orforglipron, which is still in clinical trials. Lilly expects to file for regulatory approval for obesity treatment later this year and for type 2 diabetes in 2026.

Despite Novo Nordisk’s potential first-mover advantage in the oral GLP-1 market, Lilly shares were also higher Friday, up 3.9%, rebounding from a previous session’s losses. The gains follow a volatile week in the weight loss drug sector.

Novo Nordisk’s long-term obesity strategy continues to drive investor enthusiasm, with the oral formulation potentially serving as a critical convenience upgrade. The FDA’s acceptance brings the company one step closer to expanding its GLP-1 footprint.

https://www.investing.com/news/stock-market-news/novo-nordisk-shares-jump-as-fda-accepts-wegovy-pill-application-4020688

Who’s Unpopular?

 by John Hinderaker

Chuck Schumer, for one. Democrats have been promoting the idea that Trump’s poll numbers are in the toilet, his voters are experiencing buyer’s remorse, and so on. Actually, Trump’s numbers are pretty good, and clearly better than Joe Biden’s, which is the most relevant comparison. But who is really down in the polls? A reporter asks Schumer an inconvenient question:

Politicians all swear by the polls, except when they don’t. But more significant than Schumer’s personal poll numbers, which are dragged down by antipathy from the activist wing of his party, is the fact that more broadly, the Democratic Party’s approval rating is in the 20s–way below Trump’s.

Maybe if they align themselves with more Central American gangsters and firebomb more Tesla dealerships, their numbers will improve.

https://www.powerlineblog.com/archives/2025/05/whos-unpopular.php