Drug Channels

JUNE 24, 2020

My recent tweets have highlighted: Amazon’s activities, PillPack’s bad reviews, 340B outrages, rebate reform redux, biosimilar pricing, managed Medicaid market shares, drug pricing, blockchain hype, and the warp speed vs. hyperspace debate. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc.

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Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course 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. Feldman explains unique features of the U.S. The bifurcated U.S.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%

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Vaccines Drug Pricing Biosimilars Documentation 108

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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Biosimilars Pharmaceutical Manufacturing Drug Pricing Pharmaceutical Companies 52

Drug Patent Watch

JANUARY 7, 2025

The Importance of Generic Drugs in Healthcare Generic drugs offer several benefits to patients and the healthcare system: Cost-effectiveness: Generic drugs are typically much cheaper than brand-name medications, making treatment more accessible to patients. ” WHO.int, 2020. ” AccessibleMeds.org, 2021.

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Pharmaceutical Technology

DECEMBER 9, 2022

There are also strict price controls, which in some cases can limit profitability for manufacturers. Brazilian public spending on healthcare, drug pricing reforms and remote medicine. Following the success of telemedicine during the pandemic, a bill was recently put forward to authorize its use throughout Brazil.

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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

APRIL 16, 2024

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. The statute defines a “line extension” as a “new formulation” of an existing drug, with certain exceptions. Vanda Pharmaceuticals, Inc.

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Dosage Pharmaceutical Manufacturing Drug Pricing 59

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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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

pharmaphorum

SEPTEMBER 8, 2020

billion USD will be spent in cancer care worldwide this year (2020), compared to 13.8 In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. Published on 24 June 2020. Available from : [link] [Last accessed: September 2020].

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pharmaphorum

NOVEMBER 17, 2021

With drug pricing controls back on the legislative table in the US, the influential Institute for Clinical and Economic Review (ICER) has published its third report on “unsupported” price increases – with AbbVie’s Humira top of the list.

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Drug Pricing Biosimilars 98

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. The Evergreening Myth, Fall 2020. Why 90% of clinical drug development fails and how to improve it?

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

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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Diabetes Drug Pricing Biosimilars 105

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. The company had revenues of $9.6bn both in 2020 and last year. Strong competition limits Sandoz's growth.

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pharmaphorum

MAY 13, 2022

Insulin has become the focal point of the medicine pricing debate in the US, particularly as prices have stayed high long after products have lost patent protection and are round eight times higher than in other countries, according to a 2020 report by the Department of Health and Human Services.

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Diabetes Biosimilars Drug Pricing 59

pharmaphorum

MARCH 23, 2022

All three have announced price cuts in the last couple of years, but critics say these do not go far enough to help people with diabetes who are struggling to afford their medicines. Assuming the bill is later passed by the Senate and signed into law by President Biden, the insulin cap would take effect beginning in 2023.

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Safe Biologics

APRIL 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Price controls, as proposed in the negotiation plan, may jeopardize this success. 5 * [link]

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Safe Biologics

APRIL 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Price controls, as proposed in the negotiation plan, may jeopardize this success. 5 * [link]

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drug price transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drug price transparency reporting.

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Safe Biologics

APRIL 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.

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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. The May 12 EO regarding personal importation is similar in this regard to the EO from 2020. Kevin McCarthy (Sept.

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Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

MAY 12, 2025

Kirschenbaum On September 15, 2020, I posted an article in this blog entitled Trump Embraces International Reference Pricing in Executive Order, which described an order in Trumps first administration to use most-favored-nation (MFN) pricing as a limit on Medicare payment. and other developed countries.

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FDA Law Blog: Biosimilars

MAY 21, 2025

Kirschenbaum Following up on Donald Trumps May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here ), The Department of Health and Human Services today issued a brief press release answering two of the multitude of questions raised by the Executive Order. GDP per capita. According to the U.S.

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