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Gerresheimer wins Red Dot Award

Gerresheimer, an innovative system and solution provider, received a Red Dot Design Concept award for its Gx Inbeneo autoinjector platform.




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Bormioli Pharma partners with Chiesi to supplypackaging in Carbon Capture PET

Bormioli Pharma has announced a partnership with Chiesi, an international, research-focused biopharmaceutical company (Chiesi Group), to supply Carbon Capture PET bottles.




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The FemTech Series: How to fix inequality in healthcare

In this episode of The FemTech series Olivia Friett is joined by Jane Kennedy and Dr. MaryAnn Ferreux where we will discuss the inequality in women's health and how we can overcome the obstacles that come with this.




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How are contract manufacturers driving sustainability?

Nick Guerin, CSP, director of environmental, health & safety at Tessy Plastics highlights how contract manufacturers are driving sustainability in the medical plastics industry.




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Leaders in Pharma: Thermo Fisher

In this episode of The MedTalk Podcast, we're bringing you something a little different. One of our sister publications, European Pharmaceutical Manufacturer, secured an interview with Thermo Fisher Scientific's Urmi Prasad Richardson.




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In 2024’s Record-Hottest Year, U.S. Voters Will Decide Climate’s Path Forward

Global temperatures through September point to 2024 besting 2023 as the hottest year on record. How many future years set records depends in part on the outcome of the 2024 U.S. presidential election




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Is Election Anxiety Keeping You Awake? Sleep Experts Share Advice

Scientific American staff and sleep experts share advice on how to get better sleep in the stressful days leading up to the U.S. presidential election—and those that come after




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What Made This Bizarre ‘Dandelion’ Supernova?

A strange supernova remnant first appeared as a “guest star” seen in 1181 by sky watchers in China and Japan




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Dora Richardson Took Her Research Underground to Develop Lifesaving Tamoxifen

When chemist Dora Richardson’s employer decided to terminate the breast cancer research on the drug Tamoxifen in the early 1970s, she and her colleagues continued the work in secret.




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How the 2024 Election Could Change Access to Health Care in the U.S. and Influence Global Nuclear Policies

The outcome of the 2024 U.S. presidential election could reshape policies from health care at home to nuclear proliferation abroad




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There Are Three Types of Twilight

At dusk and dawn, the sky dances with three phases of in-between light




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The International Space Station Has Been Leaking for Five Years

Pesky leaks on the International Space Station aren’t the most serious issue facing U.S. human spaceflight




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The Myth that Musicians Die at 27 Shows How Superstitions Are Made

Famous people who die at age 27, such as Janis Joplin, Jimi Hendrix and Amy Winehouse, get even more famous because of the mythology surrounding that number—an example of how modern folklore emerges




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These Bird Nests Show Signs of an Architectural ‘Culture’

Culture may play a role in how birds build collectively in the Kalahari Desert




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2024 Will Be the First Year to Exceed the 1.5-Degree-Celsius Warming Threshold

This year won’t just be the hottest on record—it could be the first to surpass 1.5 degrees Celsius. The Paris climate accord aims to keep warming below that level when looking over multiple years




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We Need Scientific Brainstorming about Shared Global Dangers

It is difficult to disentangle Russian and Chinese scientists from international science cooperation. That is a good thing




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Parents Labeling a Kid’s Friend a Bad Influence Can Backfire

Is your kid in trouble? Blaming their friends is ill advised




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Trump’s Administration Will Attack Health Care from Multiple Angles

The new Trump administration is likely to reduce subsidies for Affordable Care Act insurance plans and roll back Medicaid coverage. Public health authorities worry that antivaccine activist Robert F. Kennedy, Jr., will be empowered




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Happy Martian New Year!

The Martian new year arrives with the Red Planet’s vernal equinox. Explaining why requires a deep dive into celestial mechanics and Earth’s calendrical history




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The Lucy Fossil’s Extraordinary Journey to Becoming an Icon of Human Evolution

The 3.2-million-year-old human ancestor known as Lucy rose to fame through an incredible combination of circumstances




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I Destroyed a Car to Explore Some Music Myths

Two years of experimentation taught a Nashville guitarist not every musical myth makes sense




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A Wearable to Manage Parkinson’s Motor Symptoms: Interview with Lucy Jung, CEO at Charco Neurotech

Charco Neurotech, a medtech company based in the United Kingdom, has developed CUE1, a non-invasive wearable that is intended to assist those with Parkinson’s disease to manage their motor symptoms. The device is typically affixed to the sternum, and provides vibratory action in a focused region of the body. The technology is based on the […]




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Glasses Provide Audible Prompts for Blind Wearers

A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer […]




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Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry.

9 chapters, 350+ pages, 178 exhibits, 750+ endnotes: There is nothing else available that comes close to this valuable resource.

We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2024-25 edition at special discounted prices. This means that you can be among the first to access our new report. Those who preorder will receive a download link before October 8.
You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Special preorder and launch pricing discounts will be valid through October 23, 2024.

Read on for more details.
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Informa Connnect's Pharma/Biotech GTN Summit

Informa Connnect's Pharma/Biotech GTN Summit
November 18-20, 2024 | W Philadelphia Hotel, Philadelphia, PA
Drug Channels Readers Receive 15% Off* with Code 24DGC15.

View the Complete Agenda

Book Your Place

The complex components of gross-to-net management requires cross-functional collaboration in order to effectively develop sound accrual estimates, proper forecasting, optimized pricing and contracting models and accurate financial reporting, all with minimal disruption to market access strategies.

The CPE-accredited Pharma/Biotech GTN Summit is the ideal opportunity to engage in comprehensive sessions for end-to-end GTN excellence, connect with peers to exchange experiences and solutions to common challenges, and participate in interactive discussions that address real-world scenarios to enhance GTN accuracy and efficiency.

Featured Thought-Leaders Leading the Dialogue Include:
  • Nancy Bell, Vice President, Head of US Patient Value & Access, Takeda Oncology
  • Chris Boneham, Vice President, Market Access US, Y-mAbs Therapeutics
  • Prakash Chainani, Vice President – Finance, HR & IT, Lifestar Pharma LLC (a Mankind Group Company)
  • George Kappus, Associate Director, M&S Controlling (GtN, Boehringer Ingelheim
  • Sherri Cirota, Executive Director, Contracts & Pricing, Alkermes
  • Chris Rocco, Senior Director, Market Access Data, Reporting & Analytics, GSK
  • Rosalind Davis, Director, Government Pricing & Contracts, CSL Vifor
  • Dan Sacchetta, Director Managed Markets Finance- Gross-to-Net, Novartis
  • Eckart Beuttenmueller, Director, Gross-to-Net Execution, Bayer
  • Kinneret Klein, Executive Director, Commercial Financial Planning & Analysis, Biocryst
  • James Engel, Controller, Finance, Collegium Pharmaceuticals
  • Brett Nussbaum, Head of Gross to Net Accounting, Novartis
  • Timothy Kocses, Executive Director, US Commercial Controller, Bristol Myers Squibb
  • Robert Lucchesi, Director, FP&A Sales Reporting & Forecasting, Novo Nordisk
  • Funso Olufade, PhD, MBA, Sr. Director – Head, Commercial Finance, Ascendis Pharma
  • Amy Ramazio, Contract Forecasting & Analytics Director, GSK US Market Access
  • Ranish Singhvi, Vice President, Finance, Accord Healthcare
  • Jeffrey Miller, Assistant Vice President & Corporate Controller, Lannett Company
  • Bal Ram, SVP Finance, US Operations, Indivior
  • Matthew Pellegrini, Sr. Director - Revenue Optimization Contracting & Compliance N.A, Teva Pharmaceuticals
  • Michael Domanico, Vice President Finance, Revenue, Sandoz
  • Christopher Wang, Corporate Controller, Revance Therapeutics
  • Melissa Norton, Assistant Controller, Revenue, Tolmar
  • Michael Christiano, Director, Revenue, Ardelyx
Learn more and see why the GTN Summit remains a great choice for education and benchmarking on strategic forecasting, estimates, analytics and reporting through best practices for gross-to-net management.

Drug Channels subscribers — Save 15% when you reserve your place using the VIP code 24DGC15.

*Offer applies to the current rate and maybe not be applied to existing registrations; additional terms may apply, see website for full details.


The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).
       




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Drug Channels News Roundup, September 2024: Inside JNJ’s Gross-to-Net Bubble, Optum Rx’s Private Label Biosimilars, Where Biosimilars Boom, Accumulators vs. Patients, and Steve Collis Retires

Autumn is here! Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you:
  • Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble
  • Optum Rx joins the private label biosimilar bandwagon
  • Biosimilars boom for provider-administered drugs
  • Fresh evidence of how copay accumulators hurt patients
Plus, words of wisdom from Cencora's soon-to-be-former CEO Steve Collis.

P.S. Join my more than 58,000 LinkedIn followers for daily links to neat stuff along with thoughtful and provocative commentary from the DCI community.

There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

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NEW: The Drug Channels 2025 Video Webinar Series

Drug Channel Institute is pleased to announce The Drug Channels 2025 Video Webinar Series.

Join Dr. Adam J. Fein for three live video webinars during 2025. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia.

During these events, Dr. Fein will address the latest issues confronting the U.S. drug channel. Topics will be determined based on what’s happening—trends, policy changes, company announcements, and more. He’ll share DCI’s latest market data to help you stay on top of new developments. You will be able to use these events as both a capstone of your current learning and a touchpoint for the future.

The three events are scheduled for 12:00 p.m. to 1:30 p.m. ET on the following dates:
  • April 4, 2025
  • June 20, 2025
  • December 12, 2025 (Drug Channels Outlook 2026)
For 2025, we are offering a Corporate Pricing option that will allow larger organizations to register hundreds of colleagues for one fixed price. Please contact Paula Fein (paula@drugchannels.net) for details.

Read on for full details on pricing, including substantial discounts for multiple sites.

P.S. If you're not familiar with our webinars, click here to watch brief excerpts from our video webinars.
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Why PBMs and Payers Are Embracing Insulin Biosimilars with Higher Prices—And What That Means for Humira (rerun with an FTC update)

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs). The FTC rightly calls out how the gross-to-net bubble can raise patients’ out-of-pocket costs, while also acknowledging how rebates can reduce a plan's (but not the patient’s) costs. Apparently, the FTC believes that PBMs’ customers are pretty dumb, because PBMs are able to prevent plans from “appreciating” such healthcare financing dynamics.

Section V.E. of the complaint (starting on page 23) focuses on the PBMs’ alleged unlawful conduct related to preferring high-list/high-rebate insulin products over versions with lower list prices. I thought it would therefore be fun to take the Wayback Machine to November 2021, when I wrote about this specific topic.

Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus. Much of the FTC’s description of the drug channel aligns with my commentary. But before you fist pump too hard for Ms. Khan’s FTC, you should pause to reflect on the agency’s legal theories in light of plans’ revealed preferences.



The Food & Drug Administration (FDA) recently approved the first interchangeable biosimilar insulin product: the insulin glargine-yfgn injection from Viatris. Read the FDA’s press release.

Alas, I’m sad to report that the warped incentives baked into the U.S. drug channel will limit the impact of this impressive breakthrough.

Viatris is being forced to launch both a high-priced and a low-priced version of the biosimilar. However, only the high-list/high-rebate, branded version will be available on Express Scripts’ largest commercial formulary. Express Scripts will block both the branded reference product and the lower-priced, unbranded—but also interchangeable—version. Meanwhile, Prime Therapeutics will place both versions on its formularies, leaving the choice up to its plan sponsor clients.

Consequently, many commercial payers will adopt the more expensive product instead of the identical—but cheaper—version. As usual, patients will be the ultimate victims of our current drug pricing system.

Below, I explain the weird economics behind this decision, highlight the negative impact on patients, and speculate on what this all could mean for biosimilars’ future. Until plan sponsors break their addiction to rebates, today’s U.S. drug channel problems will remain.
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Hospitals Are Relying More on PBMs to Manage Manufacturers' 340B Contract Pharmacy Restrictions: DCI's 2024 Market Analysis (rerun)

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Click here to see the original post from June 2024.



The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:
  • About 33,000 pharmacy locations—more than half of the entire U.S. pharmacy industry—act as contract pharmacies for the hospitals and federal grantees that participate in the 340B program. 
  • Five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart—continue to dominate the 340B contract pharmacy market.
  • Federal grantees are aligned primarily with the vertically intergated organizations' retail pharmacies, while hospitals rely on mail and specialty pharmacies.
Over the past four years, manufacturers’ restrictions on 340B contract pharmacies have led hospitals to deepen their relationships with the largest PBMs—even as those PBMs have simultaneously limited hospitals’ direct participation in specialty pharmacy networks.

For an updated look at what’s next for the 340B contract pharmacy market, join Adam J. Fein, Ph.D., on June 21 for his latest live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook.
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Another IRA Surprise: Part B Coinsurance Inflation Adjustments Are Increasing Patient Costs (rerun)

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. Last night, I posted an updated analysis showing that the volatility in seniors' coinsurance rates continues. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. What's more, rates for 17 drugs returned to their original 20% level. Click here to see our original post from May 2024.



Contrary to what you may have heard, the Inflation Reduction Act’s (IRA) inflation rebates for Medicare Part B drugs do not always save money for seniors.

As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing, not declining. In many cases, the coinsurance rate declines only briefly before rebounding back to the standard 20% rate. What’s more, these fluctuations have triggered huge jumps in patients’ out-of-pocket obligations for some drugs—even when a drug’s costs were falling.

Chalk off these coinsurance surprises to yet another unintended consequence of the IRA. Seniors who are expecting to see costs drop may find they are instead being taken for a rollercoaster ride.
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NOW AVAILABLE: 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

I am pleased to announce Drug Channels Institute's new 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, available for purchase and immediate download.
We’re offering special discounted pricing if you order before October 23, 2024.

2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors—our 15th edition--remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. This 2024-25 edition includes substantial new material—outlined on page vii of the report overview.

9 chapters, 380+ pages, 178 exhibits, more than 750 endnotes: There is nothing else available that comes close to this valuable resource.

You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Email Paula Fein (paula@drugchannels.net) if you’d like to bundle your report purchase with access to DCI’s video webinars.

If you preordered the report, you should have already received an email with download instructions last week. Please contact us if you did not receive your email.

Read on for some additional details.
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As MFP Approaches, Transparency Is More Important Than Ever

Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos.

Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues.

To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape.

Read on for Angie’s insights.
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If Plan Sponsors Are So Unhappy with Their PBMs’ Transparency, Why Won’t They Change the Model?

A new survey of plan sponsors sheds light on their satisfaction with transparency at large and small pharmacy benefit managers (PBMs).

As you will see, clients remain slightly more satisfied with the perceived transparency of smaller PBMs compared with the Big Three PBMs—CVS Caremark, Express Scripts, and Optum Rx.

However, plan sponsors are dissatisfied with transparency about how both large and small PBMs make money. Smaller PBMs have an edge, but it’s narrower than you might think.

Perhaps PBMs’ clients are unable or unwilling to negotiate better deals, write more effective contracts, and switch to more satisfying relationships. Or maybe they don’t mind the current system, despite the challenges for patients. Some argue that transparency could swoop down to solve this problem. Riddle me this: Should we watch what plan sponsors say, or what they do?

Read on to see what you think of my arguments below. Then, click here to share your thoughts with the Drug Channels community.
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No More Delays: Accelerating Therapy Starts by Embedding Hub Services in Provider Workflows

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx.

Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

To learn more, download CareMetx’s new 2024 Patient Services ReportRevealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
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Drug Channels News Roundup, October 2024: Humira Price War Update, PA vs. Providers, IRA vs. Physicians, My AI Podcast, New DCI Jobs, and Dr. G on Copayments

Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats:
  • Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy
  • Vampiric! Prior authorization sinks its fangs into providers’ time
  • Wicked! How the IRA will put a stake through specialty physician practices
  • Eerie! Google’s monstrous AI podcasts leave me petrified
  • Zoinks! Join the vampire hunters at Drug Channels Institute
Plus, Dr. Glaucomflecken tells us a frightening tale of copayments.

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
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How Field Reimbursement Services Help Overcome Coverage Barriers and Improve Patient Outcomes

Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds

Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services.

To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients.

Read on for Kimberley’s insights.
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Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
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Drug Channels Outlook 2025 (NEW Live Video Webinar)

Adam J. Fein, Ph.D., president of Drug Channels Institute (DCI) and the author of Drug Channels, invites you to join him for DCI’s new live video webinar:


This event will be broadcast live on
Friday, December 13, 2024,
from 12:00 p.m. to 1:30 p.m. ET

This post describes the event and explains how to purchase a registration. (Or, just click here to order.) The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

This event is part of The Drug Channels 2024 Video Webinar Series. (Please note that our December 2024 webinar is *not* included with next year’s 2025 Video Webinar Series.)

WHAT YOU WILL LEARN

Join Dr. Fein as he helps you and your team get ready for 2025 by outlining key issues and uncertainties that will surely affect your planning. This event can be both a capstone of your annual learning and a touchpoint for the future. DCI’s Outlook webinars have proven to be reliable and informative guides to crucial aspects of the ever-evolving healthcare industry.

During the event, Dr. Fein will share his latest thinking and projections on a wide range of topics, including:
  • Latest predictions for the Inflation Reduction Act
  • Expectations for the Medicare Part D market in 2025 and beyond
  • Update on 340B Drug Pricing Program’s controversies
  • Impact of the new Trump administration and Congress on the drug channel
  • Vertical integration and consolidation trends—and prospects for dis-integration and de-consolidation
  • The state of biosimilar markets
  • What’s next for PBMs’ private label products and GPOs
  • Retail pharmacy’s future
  • Prospects for direct-to-patient channels
  • What’s ahead for discount cards and cash-pay pharmacies
  • The outlook for state and federal legislation on PBMs and the drug channel
  • Gross-to-net bubble developments
  • And much more!
PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions. The webinar will last at least 90 minutes to accommodate audience questions.

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data. He will draw from exclusive information found in DCI's economic reports .

Read on for full details on pricing and registration.
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What does the FDA do after drugs are approved? (15 seconds)

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What does the FDA do after drugs are approved? (30 seconds)

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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Medicamentos biosimilares: Lo que los pacientes deben saber

The U.S. Food and Drug Administration posted a video:

¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars




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Michelle E. Tarver, M.D., Ph.D.

The U.S. Food and Drug Administration posted a photo:

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Acting Center Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.

Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Learn more at www.fda.gov

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required. For more privacy and use information visit: www.flickr.com/people/fdaphotos/




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Geek Bar 1

The U.S. Food and Drug Administration posted a photo:

Geek Bar e-cigarette seized during joint federal operation that resulted in the seizure of $76 million of illegal e-cigarettes.




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FDA Post-Election: Continuity and Progress Likely to Mark 2013

Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more progressive environment at the agency: continuity of leadership, presidential support, and increased funding. For FDA in 2013 (as the saying goes): 2 out of 3 ain’t bad. In particular, medical innovation seems poised to flourish in an FDA environment where there is continuity of policy and leadership, instead of a new team learning the ropes. I explore this and other themes in the latest issue of Pharmaphorum.com. You can read my thoughts at: http://www.pharmaphorum.com/2013/01/29/fda-post-election-continuity-and-progress-likely-to-mark-2013/.




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The State of the FDA—February 2013

FDA is the only federal agency that touches the lives of every American several times every day. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12. Instead, FDA Matters provides its third annual “State of the FDA.” As reflected in last week’s column, I think that FDA did well in 2012. And 2013 is very promising. Potential funding cutbacks are the primary impediment to future successes.



  • Drug Approval and Access
  • FDA and Congress
  • FDA and Industry
  • FDA Leadership

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A Salmon on Every Plate/The Hard Road of Innovation

Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential. To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.




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FDA’s Indifferent Attitude Towards the First Amendment

The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives. And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights. Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.



  • Drug Approval and Access
  • FDA Accountability and Transparency
  • FDA and Industry
  • FDA Leadership
  • Insight on FDA-regulated Industries

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Revised APRA Bill Clears House Subcommittee

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]




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Former CHC Board Chairs Sharon Callahan and Nick Colucci Named as 2025 MAHF Inductees

Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]




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No, CRISPR Is Not Going To ‘Cure’ Heart Disease

No, CRISPR gene editing technology is not going to “cure” heart disease. But a New York Times story by Gina Kolata on an extremely early study in animals prominently plays up just this extremely unlikely claim. The Times story is based on a press release issued by Verve Therapeutics, a new biotechnology company founded by Sekar Kathiresan, an influential cardiologist and genomic...

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