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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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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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 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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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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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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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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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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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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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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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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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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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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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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Safe Biologics

MARCH 10, 2025

This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. Read the full statement here.

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Express Pharma

MAY 18, 2025

The recent US executive order on prescription drug pricing, signed by President Trump on May 12, 2025, aims to align American drug prices with those in other developed nations through a most-favored-nation (MFN) framework.

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Pharmacy Times

JUNE 16, 2025

According to Trump, patients could see cost reductions of 30% to 80%, but experts question the feasibility and practicality of implementing such a policy within the complex United States drug pricing and supply system. Kennedy Jr, is permitted to develop a new rule that ties American drug prices to those of other nations.

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