Safe Biologics

OCTOBER 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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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. For drugs selected for the first year of the Program, negotiations will end by August 1, 2024.

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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. Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s

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Drug Channels

MARCH 5, 2024

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s latest live video webinar: Drug Channel Implications of the Inflation Reduction Act This event will be broadcast live on Friday, April 5, 2024, from 12:00 p.m. to 1:30 p.m. All rights reserved.

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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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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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Drug Channels

MAY 29, 2024

Register now for The 340B Drug Pricing Program: Trends, Controversies, and Outlook , a new live video webinar with Adam J. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Join my nearly 56,000 LinkedIn followers for daily links to neat stuff. All rights reserved.

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Drug Channels

OCTOBER 7, 2024

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 market dynamics and barriers are impacting pricing and demand? How can I ensure compliance with ERISA requirements?

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

To that end, we were recently alerted to the fact that the Senate Committee on the Judiciary has scheduled an Executive Business Meeting for Thursday, September 19, 2024 to mark-up, among other things, two bills of interest: (1) S. But as AAM notes in a March 2024 letter opposing S. Reading through the “Findings” section of S.

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Drug Channels

OCTOBER 1, 2024

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. Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus.

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Drug Channels

JULY 23, 2024

These data remain inconvenient for drug pricing flat earthers (#DPFE): When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2023. Insulin has been the first to deflate—and the Humira biosimilar market may be next. You can find links to each company’s data below.

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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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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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Pharma in Brief

JANUARY 10, 2024

We also flag what to watch out for in 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. mL formulation in Canada”.

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pharmaphorum

JANUARY 13, 2023

The complaint – which comes as insulin has become the focal point of the drug pricing debate in the US – alleges that Novo Nordisk, Lilly, and Sanofi “aggressively raised the list price of insulin in lockstep with each other.” Some companies are already taking steps to provide lower-cost products.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. This came after an attempted sell-off starting last October was met with no formal offers from a buyer. The site employs around 250 people.

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European Pharmaceutical Review

JANUARY 18, 2024

“The dominance of the US within the 7MM is due to its larger insomnia population and higher drug prices. GlobalData considered drug pricing and market exclusivity to be two major obstacles. billion by 2024. billion across the 7MM up to 2032, GlobalData’s predicted in a report published in December 2023.

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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.

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Big Molecule Watch

MARCH 1, 2024

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA. There are now seven remaining lawsuits challenging the Drug Price Negotiation Program of the IRA.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D. On July 31, 2024, CMS published a proposed rule to codify its guidances, with some changes.

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

There have already been (with more coming) a slew of 40th anniversary celebration papers, analyses, and events in 2024, including: The Brookings Institution’s Hatch-Waxman at 40 The Association for Accessible Medicines’ Hatch-Waxman turns 40. And that name has stuck for many of us. Is it over the hill? (Or

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FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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FDA Law Blog: Biosimilars

MARCH 24, 2024

Under this law, manufacturers may not deny contract pharmacies access to a covered entity’s 340B drugs, or deny 340B drug pricing to covered entities who use contract pharmacies for distribution. On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. 22-3675, 2024 U.S. 2024) at 13 (“Decision”).

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FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. at least one drug” has been approved and marketed. 16 June 2023) Eliquis Novartis D.N.J. (1

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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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Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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pharmaphorum

MAY 13, 2022

Earlier this month, non-profit drugmaker Civica Rx pledged to launch biosimilars of three big-selling insulin products in the US – Sanofi’s Lantus, Novo Nordisk’s Novolog and Eli Lilly’s Humalog – by 2024. Some companies are already taking steps to provide lower-cost products.

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pharmaphorum

MARCH 23, 2022

Earlier this month, non-profit drugmaker Civica Rx pledged to launch biosimilars of three big-selling insulin products in the US – Sanofi’s Lantus (insulin glargine), Novo Nordisk’s Novolog (insulin aspart) and Eli Lilly’s Humalog (insulin lispro) – by 2024.

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STAT

JULY 15, 2024

In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.

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Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Negotiations over these products are expected from October 2023 and run until August 2024. Free Report.

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Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Negotiations over these products are expected from October 2023 and run until August 2024. Free Report.

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Express Pharma

FEBRUARY 10, 2025

What are the top 3 biopharma trends that you have observed in 2024 with India as a focused region as well as looking at it locally? Global trends: The emphasis on technology, AI, and generative AI is very strong within the biopharma sector, spanning areas like drug discovery, development, commercialisation, and the supply chain.

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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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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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