STAT

DECEMBER 22, 2023

WASHINGTON — Venture capitalists are still pouring money into drug research in spite of Medicare’s new power to negotiate drug prices, according to Congress’ nonpartisan budget experts. The Inflation Reduction Act includes two measures that directly lower drug prices.

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STAT

SEPTEMBER 26, 2023

Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

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pharmaphorum

APRIL 13, 2022

Unfortunately, the current drug pricing bill fails to take a holistic approach to addressing a system that drives affordability challenges for patients. Potential biosimilar impact. Outside of Congress, there is another element that could reduce the cost of insulin, in the form of biosimilars. Innovation to end debate?

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Drug Channels

OCTOBER 3, 2023

Since I published the article below in July 2023 , there have been three notable market develpoments: IQVIA has reported that as as of mid-2023, there was almost no adoption of Amgen's Amjevita, the first Humira biosimilar. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar.

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Drug Channels

JULY 18, 2023

The Humira biosimilar market has arrived! This month, nine biosimilar versions of adalimumab launched in the U.S. Surprisingly, two PBMs—Express Scripts and OptumRx—will each offer at least one low-list-price biosimilar option on their main national formularies.

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Integra X Files

APRIL 3, 2023

Drugs vs. Biologics: What’s the Difference If you ask a layperson about biosimilars, you are likely to hear comparisons to generic drugs, and that would not be completely wrong. Biosimilar products are not drugs and they are not generic, in the sense that they’re not identical to the reference product.

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Safe Biologics

JANUARY 10, 2023

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars.

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Big Molecule Watch

NOVEMBER 6, 2023

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA.

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STAT

NOVEMBER 28, 2022

A hotly contested provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare $1.5 billion from 2015 to 2020 — or nearly 5% of the $30.2 billion spent by the health care program — on just five medicines during that period, according to a new analysis.

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STAT

JANUARY 27, 2023

After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.

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STAT

NOVEMBER 15, 2023

That includes legislation to ensure seniors pay no more for drugs than insurers, and a measure that lets insurers add less-expensive biosimilars to formularies mid-year. Continue to STAT+ to read the full story…

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STAT

APRIL 16, 2024

Today, we dig into Biohaven’s plans and see Humira biosimilar prescriptions shoot up. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Read the rest…

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STAT

AUGUST 30, 2023

government’s initial approach to negotiating drug prices could discourage cheaper biosimilar versions of more complex pharmaceuticals that eat up a high portion of total Medicare spending , Bloomberg Law explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.

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Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.

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pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

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Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

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Drug Channels

DECEMBER 17, 2020

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Drug pricing perceptions always seem to lag reality. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. d/b/a Drug Channels Institute.

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STAT

MARCH 14, 2024

Damian here with a reminder that my colleague Ed Silverman is hosting a discussion today about the long-awaited arrival of Humira biosimilars and all they portend for drug costs, insurance coverage, and pharma revenues.    Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Read the rest…

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Safe Biologics

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.

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Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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Safe Biologics

DECEMBER 1, 2023

Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines. Learn more about ACR Convergence 2023 here.

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Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

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STAT

MARCH 15, 2024

Thanks to the rising use of various blockbuster drugs, but particularly the so-called GLP-1 medications for treating obesity and diabetes, the outlook for earnings for the pharmaceutical industry is positive over the next 12 to 18 months , according to Moody’s Investor Services. Continue to STAT+ to read the full story…

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Drug Channels

NOVEMBER 9, 2021

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

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pharmaphorum

APRIL 1, 2022

Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko.

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Drug Channels

APRIL 19, 2022

An ironic postcript: Less than two months after my article was published, Cigna CEO David Cordani bragged about the cost savings from "aggressive adoption" of biosimilars. Anyone want to tell him about the Express Scripts formulary for insulin biosimilars? drug channel will limit the impact of this impressive breakthrough.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list.

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Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the poster here.

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Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the poster here.

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Safe Biologics

FEBRUARY 1, 2024

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “ Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines” The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

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Drug Channels

JULY 27, 2021

In this issue: The top 10 stingiest hospitals Medicare Part B's savings from biosimilars What happened to hepatitis C drug costs and rebates? Let’s cut through the summer haze with our refreshing breeze of articles and insights. Costco beats Medicare Part D Plus, math madness with Duke’s Fuqua business school.

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STAT

MARCH 3, 2023

… Now that Eli Lilly slashed the price for some of its insulin products, the moves raised questions about what will happen to other efforts to provide low-cost insulin, Kaiser Health News explains. And the Mark Cuban Cost Plus Drug Co. But drug=pricing experts predict Lilly’s moves will not undercut those efforts.

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Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. billion in funding, a $226 million increase on the previous year.

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STAT

FEBRUARY 9, 2023

WASHINGTON — The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms. Its basic patent expired in 2016. Continue to STAT+ to read the full story…

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