STAT

JULY 18, 2023

Now that biosimilar versions of Humira are starting to arrive, what happens next? Will this finally prove the case that biosimilars can deliver on big health care savings? What key signals will indicate how biosimilars might be prescribed, or paid for? Read the rest…

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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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Drug Pricing Biosimilars Drug Development 357

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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Drug Pricing Biosimilars 297

STAT

JULY 15, 2024

Novo said it has given patients enough time to switch to other options, but is unaware of plans for drugmakers to produce a biosimilar version of the insulin, although Novo would not assert any patent against such a version.

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Drug Pricing Biosimilars Diabetes 279

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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Labelling Biosimilars Drug Pricing 257

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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Biosimilars Drug Pricing 246

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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Drug Pricing Biosimilars 329

Safe Biologics

DECEMBER 8, 2023

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. The webinar was the fourth in a series covering key health policy issues.

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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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Biosimilars Drug Pricing 267

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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Biosimilars Insurance Coverage and Processing Drug Pricing Diabetes 119

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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Biosimilars Drug Pricing 275

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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Biosimilars Drug Pricing Drug Development 297

STAT

SEPTEMBER 6, 2023

Congress previously drew this dubious distinction in 2010, when the biosimilar pathway it set up via the Biologics Price Competition and Innovation Act (BPCIA) conferred 12 years of data exclusivity on originator biologics, seven more than is given to originator small molecules under the Hatch-Waxman Act.

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Biosimilars Drug Pricing 340

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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Biosimilars Drug Pricing 98

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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Biosimilars Drug Pricing Labelling 98

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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Drug Pricing Biosimilars 246

Drug Patent Watch

DECEMBER 26, 2024

The FDA has also demonstrated that greater competition among generic drug makers can lead to lower generic drug prices. Studies have shown that the market entry of just a few generic competitors can yield generic prices below the brand price, and that generic drug prices decline with additional competition.

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Drug Pricing Biosimilars 98

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 Pricing Biosimilars Diabetes 270

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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Biosimilars Drug Pricing 100

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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Biosimilars Drug Pricing 246

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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Biosimilars Drug Pricing 78

Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

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Biosimilars Drug Pricing Drug Development 130

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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Biosimilars Labelling Drug Pricing Packaging 130

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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Biosimilars Drug Pricing 75

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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Biosimilars Drug Pricing 75

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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Biosimilars Drug Pricing Packaging Labelling 130

Drug Channels

SEPTEMBER 28, 2021

Curl up with your favorite pumpkin-spiced blog and savor these stories harvested from the Drug Channels patch: Fresh insights about hospitals’ specialty drug profits SSR Update: Drug prices keep dropping My $0.02 You can also find me on LinkedIn , where I have more than 20,000 followers.

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Drug Pricing Hospitals Biosimilars 81

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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Biosimilars Drug Pricing 130

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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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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Biosimilars Drug Pricing 52

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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Biosimilars Drug Pricing Drug Development 130

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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Biosimilars Drug Pricing Drug Development 130

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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Drug Pricing Biosimilars 53

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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Drug Channels

OCTOBER 27, 2021

So grab your pillow case and stuff it with treats from the great Drug Channels pumpkin patch: Spooky! PBMs are conjuring a terrifying number of formulary exclusions for oncology drugs Eerie! It’s the biosimilar boom! d/b/a Drug Channels Institute. Brrr.did you hear that? Believe it or not, U.S

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Biosimilars Hospitals Independent Pharmacies Drug Pricing 75

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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Drug Pricing Biosimilars 100

pharmaphorum

MAY 12, 2021

Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Humira is due to face competition from a gang of cheaper biosimilar near-copies in 2023, when the blockbuster drug’s patent protection runs out in the US.

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