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 Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. CVS Health launched Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. The Humira biosimilar market has arrived!

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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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. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc.

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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.

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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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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Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. WEZLANA is the first product to be approved as a biosimilar to STELARA.

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Express Pharma

FEBRUARY 21, 2024

The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA). trillion on 31 December 2023, reveals GlobalData.

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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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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. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia. Friday, December 16, 2022 12:00 p.m. to 1:30 p.m.

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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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Safe Biologics

FEBRUARY 1, 2024

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “ Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines” The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023.

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pharmaphorum

APRIL 1, 2022

Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko.

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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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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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Drug Channels

MARCH 14, 2023

I am pleased to announce our new 2023 Economic Report on U.S. 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 Analyzes Impact of Inflation Reduction Act on U.S. The 2023 Economic Report on U.S.

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Pharma in Brief

JANUARY 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. The most significant legal development in 2023 was the introduction of a system of patent term adjustment ( PTA ). In November 2023, the PMPRB launched its consultation on new guidelines (see here ).

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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. drug pricing, reimbursement, and dispensing system. Special preorder and launch pricing discounts will be valid through April 3, 2023.

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Drug Channels

MARCH 5, 2024

The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia. This event is part of The Drug Channels 2024 Video Webinar Series. The IRA’s impact will extend far beyond the Medicare program into many aspects of the overall drug channel.

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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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Drug Channels

NOVEMBER 14, 2023

Fein, CEO 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 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. This event is part of The Drug Channels 2023 Video Webinar Series.

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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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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. A complete agenda is available here. Hyman, Phelps & McNamara, P.C.’s

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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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Drug Channels

OCTOBER 15, 2023

Informa Connect’s PBM Contracting Summit December 5-6, 2023 in Chicago, IL Drug Channels readers save 10% with code 23DRCH10 * Join your peers for a unique opportunity to navigate the complex PBM landscape and gain unparalleled strategies to improve patient care and manage costs. Drug Channels, or any of its employees.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

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Pharmaceutical Technology

DECEMBER 20, 2022

The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. The FDA also awarded priority review for Eli Lilly’s donanemab, a monoclonal antibody for Alzheimer’s disease, in August 2022, and the company expects approval by February 2023. and 10%, respectively.

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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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Pharmaceutical Technology

FEBRUARY 8, 2023

Pfizer is likely to continue maintaining its position by breaking into the race for a respiratory syncytial virus (RSV) vaccine; it is currently awaiting FDA marketing approval for its RSV vaccine, which was awarded priority review with a PDUFA date decision in May 2023.

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FDA Law Blog: Biosimilars

JUNE 26, 2023

Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. By Faraz Siddiqui & Alan M. federal district court on June 6 (see our post here ).

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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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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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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. The drug was indeed selected on August 29, 2023.

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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). As such, the court held that FDCA does not preempt Act 1103.

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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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European Pharmaceutical Review

JANUARY 18, 2024

billion by 2023, driven by the launch of Merck’s Belsomra and Eisai’s lemborexant (E-2006). GlobalData’s Analyst covering Neurology and Ophthalmology, Thomas Parker, MPharmacol, predicted that Belsomra would lead the market by 2023. GlobalData considered drug pricing and market exclusivity to be two major obstacles.

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