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

NOVEMBER 15, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2022. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. The Outlook 2022 marks our third annual outlook webinar. to 1:30 p.m.

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Drug Channels

NOVEMBER 9, 2022

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2023. Friday, December 16, 2022 12:00 p.m. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia. to 1:30 p.m.

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Drug Channels

MARCH 5, 2024

This event is part of The Drug Channels 2024 Video Webinar Series. WHAT YOU WILL LEARN In 2023, the Inflation Reduction Act of 2022 (IRA) began to alter the Medicare Part D program and trigger changes in beneficiary out-of-pocket spending, drug prices, pharmacy economics, and market access strategies.

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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. trillion Consolidated Appropriations Act.

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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. Cited 25 September 2022]. Cited 25 September 2022]. Letter to FDA, 06 July 2022.

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Pharmaceutical Technology

DECEMBER 15, 2022

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.

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European Pharmaceutical Review

JANUARY 18, 2024

billion in 2022 to $4.1 percent between 2022 and 2032. percent between 2022 and 2032. 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. percent from $3.2

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Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Coronavirus Disease 2019 (Covid-19) Analyst Consensus Sales Analysis and Forecast, H1 2022 , Comirnaty is the leading prophylactic Covid-19 vaccine and recorded sales of $41.3bn in 2021. AbbVie reported a 22.7%

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Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.

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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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Drug Channels

NOVEMBER 22, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.

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Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. FDA Law Blog readers can receive a 10% discount off the conference registration price.

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Drug Pricing 64

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023 edition at special discounted prices. A new Section 12.5.

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Pharmaceutical Technology

APRIL 20, 2023

As of 1 April 2023, Japan’s latest ‘off-year’ National Health Insurance (NHI) drug price revisions for FY2023 have now come into effect. While roughly 100 drugs received additional price premiums, the majority of products saw their price reduced as a result of discrepancies between their NHI and market prices.

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Pharmaceutical Technology

DECEMBER 20, 2022

trillion in Q2 2022 to $3.14 The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. GSK and Sanofi’s share prices dropped sharply by 46.4% billion for Q3, according to GlobalData’s Drugs Database. and 10%, respectively.

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Drug Channels

MARCH 14, 2023

drug pricing, reimbursement, and dispensing system. The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers , our 14th edition, provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S.

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui & Sophia R.

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Drug Channels

NOVEMBER 23, 2021

Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.

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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

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. The primary manufacturer of a selected drug may also request CMS to terminate its agreement if they are unwilling to participate in the Medicare Drug Price Negotiation.

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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. Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir. We wrote a memorandum summarizing CMS’ regulation here.

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Dosage Drug Pricing Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S.

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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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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. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed.

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Drug Pricing 59

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

MARCH 23, 2022

The US Senate will vote in the coming weeks on whether to introduce a $35 cap on the monthly cost of insulin to patients that was endorsed by President Joe Biden in his 2022 State of the Union address. Expressing his support for the bill last month, he claimed that one in four Americans are being forced to ration insulin doses due to cost.

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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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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. We anticipate that the government will continue to advance the Digital Charter Implementation Act, 2022 (Bill C-27).

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Pharmaceutical Technology

JUNE 2, 2023

In a bit to challenge the market dominance of AbbVie’s Humira (adalimumab), the online pharmacy Cost Plus Drugs, owned by billionaire Mark Cuban has announced a plan to market Coherus Biosciences’ biosimilar Yusimry (adalimumab-aqvh), Cost Plus Drugs will be offering Yusimry at $569 per unit, excluding shipping and dispensing charges.

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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. of the total value of pharmaceutical market sales, with the value of generics sales forecast to grow to $5.7bn in 2022.

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pharmaphorum

JANUARY 22, 2021

We don’t believe there will be draconian price cuts, for the same reason. The Biden administration could put additional scrutiny on drug prices, but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely.”.

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