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.

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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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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.

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The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:Read more »

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.

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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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Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx.

Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

To learn more, register for AssistRx's free webinar on October 8: Meet Your Patients Where They Are & Gain Visibility: Even at Retail.

Read on for Timothy’s insights.
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Informa Connect’s PBM Contracting Summit
December 10-11, 2024 | Chicago, IL
Drug Channels readers save 10% with code 24DRCH10*

Experts from across the US come together each year at the PBM Contracting Summit to gain innovative and practical contracting strategies, master PBM innovation and design, improve patient care management and rising costs, understand the current legislative issues impacting contract negotiations and more. Join us in Chicago (or virtually) where you’ll benefit from two days of learning, education and networking, and will return to the office having mastered the complex PBM landscape.

You’ll hear from Matthew Gibbs, Pharm.D., Pharmacy Transformation Leader of Blue Shield of California as he leads a comprehensive discussion on the PBM landscape over the last year, and delves into the evolving trends and emerging challenges shaping the current industry today.

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions:

• What are the latest legislative updates and proposed federal bills impacting PBM operations?
• What's on the horizon for alternative PBMs? What are the top intricacies of rebate eligibility? What are the market impacts of innovative models such as Mark Cuban's Cost Plus Drugs and Amazon's pharmacy model?
• What can be learned from the J&J lawsuit? Review the expansion of data access and the importance of employer's fiduciary duties.
• What are the challenges of vertical integration?
• How do PBMs manage their contracting processes with plan sponsors to create successful contracts?
• What are the most effective strategies for spread pricing and reimbursement models?
• What is the best solution to navigate the challenges of the 340B drug pricing program and PBM contracting?
• What is the best way to design and optimize benefits for covering GLP-1s?
• How can I ensure compliance with ERISA requirements?
• What are the latest developments in copay maximizer and accumulator programs?
• What market dynamics and barriers are impacting pricing and demand?
• What can be learned from the economic landscape of biosimilars and specialty therapeutics?
• And much more!

View the agenda for the PBM Contracting Summit to see the complete picture – the program, speakers, and more, visit www.informaconnect.com/pbm-contracting for further details and to register. Drug Channels readers will save 10% off when they use code 24DRCH10 and register prior to November 8, 2024.*

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rates or other offers. Other restrictions may apply.

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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).

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.

• Download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits)

• Review pricing/license options and download the full 2024-25 report

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 regular readers of Drug Channels know, U.S. distribution and dispensing channels for prescription drugs are undergoing significant evolution and consolidation as the changing economics of pharmaceuticals challenge conventional business models.

During this period of volatility, the core business model of the Big Three public pharmaceutical distribution companies—Cardinal Health, Cencora, and McKesson—remains intact. Put simply: Buy low, sell high, collect early, and pay late.

But as I explain below, wholesalers continue to position themselves as essential intermediaries by expanding their industry position and strengthening their economic fundamentals.

Read on for five key pricing, pharmacy, provider, and manufacturer trends that are driving the U.S. drug wholesaling industry.

For even more, check out DCI's new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, the fifteenth edition of our deep dive into wholesale distribution channels.Click here to download a free report overview (including key industry trends, the table of contents, and a list of exhibits)
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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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Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
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Reality has again failed to support the spin surrounding the 340B Drug Pricing Program.

For 2023, discounted purchases under the 340B program reached a record $66.3 billion—an astounding $12.6 billion (+23.4%) higher than its 2022 counterpart. The gross-to-net difference between list prices and discounted 340B purchases also grew, to $57.8 billion (+$5.5 billion). 340B purchases are now almost 40% larger than Medicaid’s prescription drug purchases.

Hospitals again accounted for 87% of 340B purchases for 2023. Purchases at every 340B covered entity type grew, despite drug prices that grew more slowly than overall inflation.

Lobbyists claim that manufacturers’ 340B contract pharmacy changes are “stripping billions of dollars from the healthcare safety net.” But every year, the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.

Read on for full details and our analysis, along with fresh details of troubling behavior by the Health Resources and Services Administration (HRSA).
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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 Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
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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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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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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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Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx.

Chris examines three key trends that will affect patient support programs: the Inflation Reduction Act (IRA), legal/regulatory battles over copay adjustment programs, and uncertainties following a national election. He then outlines three actions that should guide manufacturers' preparation.

To learn more, register for ConnectiveRx’s free webinar on December 11: The Perfect Storm? Patient Support Programming in 2025 and Beyond.

Read on for Chris’s insights.
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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:

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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ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard and Kristen Surdam to discuss ACRO’s new D&I Site Resource Grants Program.

The post Bonus Episode: Fast Facts on the ACRO D&I Grants Program first appeared on ACRO.

Bonus Episode: Fast Facts on the ACRO D&I Grants Program ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristen Surdam (ACRO D&I Steering Committee Member) to discuss ACRO’s new D&I Site Resource Grants Program. They provide background on the […]

The post Bonus Episode: ACRO’s Good Clinical Podcast first appeared on ACRO.

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

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

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

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

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

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

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

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

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

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.

On December 3, a federal appeals court ruled against one of the FDA’s untouchable restrictions on industry—thou shalt not promote the off-label use of pharmaceutical products. An industry that is little interested in constitutional law suddenly finds itself talking about the First Amendment and whether, and on what grounds, the case will be appealed. Meantime, the court’s decision left FDA Matters torn between cheering and booing. Patients are poorly served if their doctor is prescribing drugs without being able to tap into all sources of relevant knowledge. However, permitting off-label promotion undercuts the incentive for companies to thoroughly investigate the safety and efficacy of a drug for a second or third use.

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear.

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.

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million between now and September 30, 2013. This will reduce inspections, slow drug and device approvals, and restrict implementation of the Food Safety Modernization Act and other recent legislation. Because of the many questions about the process and outcome, this is FDA Matters’ primer on the sequester of FDA funds.

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 […]

On May 24, Governor Tim Walz signed into law Minnesota’s new comprehensive data privacy law, the Minnesota Consumer Data Privacy Act (HF 4757 referenced as the MCDPA). The MCDPA goes into effect on July 31, 2025, with some exceptions for colleges and universities (who have until 2029). The MCDPA is similar to other state privacy laws, […]

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]

Agencies with healthcare clients in pharmaceuticals, healthcare services, digital health apps, or health-related connected devices such as wearables should take note that the Federal Trade Commission (FTC) final rule updating its Health Breach Notification Rule (HBNR) that took effect on July 29, 2024. The FTC considers a breach to include a covered entity’s unauthorized disclosure […]

Effective on October 21st of this year, the Federal Trade Commission (FTC) issued a new final rule that is intended to better combat ​“fake” reviews and testimonials by prohibiting the sale or purchase of “fake reviews” as well as granting the agency the opportunity to seek civil penalties against ​willful violators. The FTC made only […]

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 […]

Note to readers: After a period of inactivity CardioBrief is coming back, but with some big differences. This website, CardioBrief.Org, will remain my personal website. A new website, CVCTCardiobrief.com, will be the new home for my “professional” blogging activities. To develop this website I have joined forces with the global CVCT Forum. I look forward to...

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It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is...

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At this moment in time the pre-pandemic cardiology research agenda needs to be completely reprioritized. There are two broad areas that now take precedence over all existing research concerns. On the one hand, researchers need to achieve a better understanding of the staggering incidence of deferred or delayed treatment of cardiovascular events and conditions as...

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<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

<p>On 3^&nbsp;June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>

<p>The global biologicals market surged to an impressive US$419.07 billion in 2023. Blood and blood products led the market, commanding a dominant 66% share. Oncology stood out as the leading application segment, accounting for 36% of the market. North America held the largest revenue share, at 46%, while the Asia-Pacific region emerged as a rising star, poised to be the fastest-growing region over the next decade.</p>

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>

<p> <b>BIOSIMILAR RED TAPE ELIMINATION ACT (S2305):</b><br /> <b><i>Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health</i></b><br /><b>31 October 2024&nbsp;|&nbsp;</b><b><a href="https://youtu.be/X6-dYZ7fjhM" target="_blank">WATCH REPLAY</a></b></p>

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>

The Pharmaceutical Services Negotiating Committee is in talks with the government over potential plans to distribute COVID-19 treatments in primary care.

Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal.

The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence.