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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Drug Pricing Biosimilars Dosage Documentation 45

Pharma in Brief

NOVEMBER 12, 2023

The Board indicated that a “What We Heard” document will be released in 2024. The deadline for registration in the roundtables is November 24, 2023. The deadline for written submissions in response to the scoping paper is December 20, 2023.

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Drug Pricing Documentation 52

Big Molecule Watch

OCTOBER 2, 2023

Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act. New Complaint by Novo Nordisk Also on Friday, Novo filed a new Complaint challenging the Drug Price Negotiation Program and CMS’s actions in implementing it.

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STAT

MAY 18, 2023

Federal Trade Commission is widening its probe into pharmacy benefit managers and their impact on drug pricing by looking into a pair of group purchasing organizations that are owned by these industry middlemen, but are not well understood outside the industry , STAT reports. Deputy Assistant Attorney General Sarah Harrington said.

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STAT

DECEMBER 29, 2022

Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug Administration and Biogen to chronicle how a controversial Alzheimer’s disease drug was approved, and how it went from what was supposed to be the biggest drug launch in history to a financial catastrophe.

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Documentation Drug Pricing 246

STAT

SEPTEMBER 15, 2022

In their filing , which was made in 2019, the groups argued that “unlawful conduct” carried out by Gilead had hurt the public interest, because its prices led the government to ration the Sovaldi medication. Continue to STAT+ to read the full story…

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Documentation Drug Pricing 228

STAT

DECEMBER 29, 2022

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

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Drug Channels

MARCH 16, 2021

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: The Latest Trends for U.S. Drug Pricing, Reimbursement, and Patient Costs (press release) We’re offering special discounted pricing if you order before March 28, 2021.

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Drug Channels

JULY 21, 2020

Last week, I documented that nearly half of U.S. pharmacies now participate in the 340B Drug Pricing Program. Below, we update our exclusive analysis of the biggest specialty pharmacies within 340B.

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Specialty Pharmacies Drug Pricing Documentation Hospitals 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s Drugs Database, Rinvoq and Skyrizi combined are projected to reach global analyst consensus forecast sales of more than $21bn by 2028. Bristol Myers Squibb (BMS) documented a 9.1%

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Vaccines Drug Pricing Biosimilars Documentation 108

Drug Channels

MARCH 15, 2022

drug pricing, reimbursement, and dispensing system. There are loads of internal hyperlinks to help you navigate the document and customize it to your specific interests and priorities. The 2022 Economic Report on U.S. The report has been thoroughly updated with the latest data and includes loads of new material and new sections.

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Specialty Pharmacies Drug Pricing Pharmaceutical Manufacturing Documentation 85

Safe Biologics

FEBRUARY 1, 2024

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development On January 25, the European Medicines Agency’s (EMA’s ) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical (..)

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Biosimilars Documentation Drug Pricing 130

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 employee count cut-off in all small entity definitions has increased from 50 to fewer than 100.

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STAT

FEBRUARY 9, 2023

WASHINGTON — The Biden administration on Thursday offered the first glimpse into how it’s planning to enact a new law that will penalize drugmakers for hiking their prices faster than inflation.

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Drug Pricing Documentation 222

pharmaphorum

NOVEMBER 3, 2022

Measures in the leaked document could allow pharma companies to extend their monopolies beyond the end of the original 20-year patent term, and shut down so-called ‘pre-grant’ channels that can currently be used to block unjustified patents before they are granted.

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Documentation Drug Pricing 85

Pharma Leaders

JUNE 1, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

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pharmaphorum

MAY 14, 2021

Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA.

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pharmaphorum

JUNE 10, 2021

Against this backdrop, there has been substantial public debate about rising drug prices forced on consumers, including the trite notion that pharmaceutical companies are being “greedy” and seeking to price-gouge the public. The truth about rising drug prices is more nuanced and merits exploration.

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Drug Pricing Vaccines Pharmaceutical Companies Pharmaceutical Companies 105

Viseven

JANUARY 13, 2023

The list of HEOR competencies includes, but is not limited to, clinical trial design, epidemiology, HEOR modeling, statistics, data mining, collecting and processing statistics and documenting real-world evidence. How Pharmaceutical HEOR Experts impact Drugs Engineering. HEOR Impact on Drug Pricing and Marketing.

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Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 40

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

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Biosimilars Drug Pricing Documentation Labelling 130

STAT

JUNE 6, 2023

WASHINGTON — Medicare has chosen a Center for Medicare and Medicaid Innovation official to temporarily lead its implementation of Democrats’ drug pricing law, a document obtained by STAT shows.

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Drug Pricing Documentation 237

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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Biosimilars Drug Pricing Dosage Documentation 57

Ramblings of a pharmacist

FEBRUARY 16, 2022

It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics. It’s an invaluable document, even if it isn’t perfect. How much were they?). In other words, the $55.96

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Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling 52

Proxsys Rx

APRIL 19, 2024

HRSA issues “Administrative Dispute Resolution” ruling On April 19, HRSA issued a ruling entitled “340B Drug Pricing Program; Administrative Dispute Resolution.” The ruling is an estimated 19,247 words long, or just over 37 pages, printed in single-spaced 10-point Arial.

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Specialty Pharmacies Hospitals Drug Pricing Packaging 52

STAT

JULY 24, 2023

AbbVie, Teva Pharmaceutical, and AstraZeneca left over a span of five months following the passage of the drug-pricing reform law pushed by Democrats last year. Financial interests were often not clearly disclosed in NICE documents.

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Drug Pricing Documentation 216

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy.

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STAT

MAY 1, 2023

Senators drafting reforms to the drug middlemen industry have delayed their effective date by at least 10 months, according to new documents obtained by STAT. WASHINGTON — Pharmacy benefit managers may have gotten themselves a slight reprieve.

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Documentation Drug Pricing 244

Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. Gilenya is an oral medication for multiple sclerosis.

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pharmaphorum

NOVEMBER 5, 2020

Pharma may have avoided a worst case scenario amid the political upheavals in the US elections with the threat of tough drug price legislation lowered, with hawkish Democrats unlikely to win overall control of Congress. It would also aggressively push this policy for self-administered (part D) Medicare drugs, according to Jefferies.

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Drug Pricing Biosimilars Documentation 105

Ramblings of a pharmacist

FEBRUARY 18, 2022

These fees, as documented by CMS, have increased by 109,000% in the past 10 years. I consult with pharmacies to help them understand “DIR fees” – the post-adjudication fees that PBMs contractually force upon pharmacies as a condition of accepting taxpayer-subsidized Medicare Part D business.

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Grocery Stores Specialty Pharmacies Drug Pricing Documentation 40

pharmaphorum

OCTOBER 29, 2021

One administration official told reporters that the party was unable to overcome divisions in its ranks in both the House and Senate in the face of an intense lobbying effort by the pharma industry, which has long argued that hitting pricing would harm their ability to carry out R&D and bring new therapies to market.

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