Pharmaceutical Commerce

JUNE 17, 2025

AI in value-based pricing and RWE generation AI has the potential to transform value-based pricing (VBP) by leveraging machine learning for dynamic pricing models that adjust drug prices based on real-world patient outcomes. Serialization 2.0: Why It’s Time to Upgrade, and What’s at Stake John F.

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pharmaphorum

JUNE 12, 2025

Importantly, this type of insight also supports smarter negotiations around drug pricing. In communities where there is only one pharmacy – or none – there is no competition to drive down prices. By identifying these regions, PBMs can better advocate for fair pricing models that reflect real-world access challenges.

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FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (

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Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

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Big Molecule Watch

JANUARY 14, 2025

As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last years recap of 2023 , Regenerons litigation against multiple aflibercept biosimilar competitors tops our chart this year.

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Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. That litigation is ongoing.

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Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

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Pharmaceutical Technology

JULY 4, 2025

July 4, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Vevzuo is authorised to prevent bone complications in adults with advanced cancer in bone and treat GCT of bone. Biocon Biologics’ Denosumab biosimilars, Vevzuo and Evfraxy, have received marketing authorisation in the European Union (EU).

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Pharma Marketing Network

MAY 11, 2025

accelerates its crackdown on drug pricing through new legislation and regulatory enforcement, pharma companies in China, India, Japan, and South Korea are feeling the ripple effect. This move marked a major shift in how drug pricing is managed in the United Statesa market that contributes significantly to global pharma revenues.

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Pharmaceutical Technology

JULY 7, 2025

July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Ekterly is intended for treating acute attacks of hereditary angioedema. In April 2025, KalVista Pharmaceuticals granted Kaken Pharmaceutical the commercialisation rights for sebetralstat in Japan. How will RFK Jr’s American dream for vaccines play out?

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Putting Patients First Blog

JANUARY 27, 2025

Formulary Inclusion and Placement of Generics and Biosimilars The NHC supports CMS proposals to improve formulary practices by prioritizing access to generics, biosimilars, and other cost-effective medications in the Medicare Part D program.

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Pharmaceutical Technology

JULY 1, 2025

Frankie Fattorini July 1, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The EU Pharma Package’s attempt to balance priorities risks achieving none. Go deeper with GlobalData Reports Chemotherapy in Pharmaceuticals: Platinum-based cancer drug composi. How will RFK Jr’s American dream for vaccines play out?

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Pharmaceutical Commerce

JUNE 16, 2025

24 Hours in the Hub Still Matters More June 16, 2025 By Chris Dowd, ConnectiveRx Commentary Article Pharmaceutical Commerce Pharmaceutical Commerce - June 2025 Volume 20 Issue 3 Doubling down on patient access and support fundamentals will win out over Washington’s next move. Chris Dowd Key Takeaways Speed is Critical.

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Pharmaceutical Technology

JULY 2, 2025

Robert Barrie July 2, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Analysis by GlobalData’s Pharma Intelligence Centre forecasts Alyftrek will bring in sales of $6.1bn by 2031. Kaftrio loses patient protection in 2037, at which point biosimilars are set to enter the market. JHVEPhoto via Shutterstock.

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Pharmaceutical Technology

JULY 7, 2025

July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Pivya has been proven safe in three studies. Alembic plans to make Pivya available in the US in the fourth quarter of 2025.” How will RFK Jr’s American dream for vaccines play out? Credit: Summit Art Creations/Shutterstock.

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Pharmaceutical Technology

JULY 7, 2025

July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The collaboration will advance paediatric healthcare by focusing on cell and gene therapies. How will RFK Jr’s American dream for vaccines play out? Credit: Department of Health Abu Dhabi. Login Registration is disabled.

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Pharmaceutical Technology

JULY 7, 2025

July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The early stages of formulation development and analytical testing can be some of the most exciting phases of drug development, fueled by the anticipation that follows the discovery of a promising new active pharmaceutical ingredient (API) or combination.

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FDA Law Blog: Biosimilars

MARCH 12, 2025

The American Conference Institutes 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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Pharmacy Times

JUNE 23, 2025

Soefje, PharmD, MBA, BCOP, during the Hematology/Oncology Pharmacy Association (HOPA) 2025 Annual Conference in Portland, Oregon. This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs.

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Pharmaceutical Commerce

JUNE 13, 2025

Bill Roth Key Takeaways Price hikes, not launch prices, drove the GTN bubble. The real driver of the gross-to-net (GTN) bubble was the pharmaceutical industry's ability to raise drug prices year after year—enabled by loopholes in PBM contracts—rather than high launch prices alone.

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Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. The amendments are scheduled to come into force no later than January 1, 2025. mL formulation in Canada”.

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Pharmaceutical Commerce

JUNE 17, 2025

How Recent Executive Orders Impact the Drug Pricing Landscape Nicholas Saraceno, Editor May 30th 2025 Podcast Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

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Pharmaceutical Commerce

JULY 1, 2025

February 7, 2025. Accessed July 1, 2025. Nicholas Saraceno, Editor June 26th 2025 Article Analysis compares care quality and efficiency within physician groups that treat Medicare Advantage patients under at-risk contracts, versus fee-for-service. Related Content Does Risk-Based Payment Drive Better Care in Medicare Advantage?

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Pharmaceutical Technology

JULY 7, 2025

Robert Barrie July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference. How will RFK Jr’s American dream for vaccines play out? Login Registration is disabled.

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Pharmaceutical Commerce

JUNE 18, 2025

How Recent Executive Orders Impact the Drug Pricing Landscape Nicholas Saraceno, Editor May 30th 2025 Podcast Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access. JAMA Netw Open. 2025;8(6):e2513394.

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STAT

MAY 8, 2025

Medicare drug plans significantly boosted coverage of biosimilar versions of the Humira rheumatoid arthritis medicine this year, but nearly all of them failed to take steps that would encourage greater use of these alternative treatments, a new government watchdog report finds. And some did not cover the brand-name version.

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pharmaphorum

JUNE 18, 2025

EYs latest Biotech Beyond Borders report acknowledges the seismic changes in the US in the last few months, including cuts to NIH funding , staff reductions at the FDA which could affect its ability to review and approve new products, the threat of tariffs on medicines, and new drug pricing proposals such as Trumps most favoured nation policy.

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Express Pharma

FEBRUARY 10, 2025

There is significant potential to harness these capabilities within the Indian economy to advance the biopharma sector, particularly in the development of drugs for domestic manufacturing companies. India is streamlining processes for faster approvals of biologics and biosimilars, aiming to speed up access to effective therapies.

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pharmaphorum

JUNE 17, 2025

So if we can reduce some of the unnecessary cost and time of the six to 15 months toxicity and animal testing period, we can lower barriers to entry, we can lower R&D costs, and we can ideally lower drug prices, which is a big goal for this administration.” Oncology IMUNON at ASCO 2025: Changing the micro-tumour environment i.

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FDA Law Blog: Biosimilars

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. Of interest to these bloggers is the provision that deals with personal use importation.

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Big Molecule Watch

MAY 15, 2025

In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (EO 273), titled Lowering Drug Prices By Once Again Putting Americans First.

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Pharmaceutical Technology

JULY 4, 2025

Robert Barrie July 4, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Only 4% of global drugs sales in 2030 will have patent protection. Biosimilars and generics flood the market upon patent loss, which exerts pricing pressure on the branded product. LanKS via Shutterstock.

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Pharmaceutical Technology

JUNE 27, 2025

Compounded GLP-1RAs have completely disrupted pricing frameworks for Wegovy and Mounjaro, what happens now? Robert Barrie June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The list price for a month’s supply of 2.4mg Wegovy – the drug’s highest does – is $1,350 in the US, whereas the same dose in the UK costs £175.80

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Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. This event is part of The Drug Channels 2024 Video Webinar Series.

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Pharmaceutical Commerce

JUNE 13, 2025

The Trump Administration has revived the most-favored nation (MFN) drug pricing model as a seven-year test, which would tie US drug prices to the lowest prices paid by certain OECD countries—an approach previously blocked by courts. Concerns over price controls. What is MFN model pricing?

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Pharmacy Times

JUNE 12, 2025

President Trump Signs Executive Order to Create Most Favored Nations On May 12, 2025, President Donald J. President Trump Signs Executive Order to Create Most Favored Nations On May 12, 2025, President Donald J. 1 The order attempts to set price targets that are equal to or less than those of other “comparably developed nations.”

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