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.”

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

Biosimilars 130

Biosimilars Drug Pricing 130

Drug Patent Watch

DECEMBER 26, 2024

The FDA has also demonstrated that greater competition among generic drug makers can lead to lower generic drug prices. Studies have shown that the market entry of just a few generic competitors can yield generic prices below the brand price, and that generic drug prices decline with additional competition.

Drug Pricing 96

Drug Pricing Biosimilars 96

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!

Biosimilars 98

Biosimilars Drug Pricing Labelling 98

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.

Biosimilars 119

Biosimilars Insurance Coverage and Processing Drug Pricing Diabetes 119

Safe Biologics

DECEMBER 1, 2023

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines.

Drug Pricing 100

Drug Pricing Biosimilars 100

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.

Biosimilars 98

Biosimilars Drug Pricing 98

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.

Specialty Pharmacies 98

Specialty Pharmacies Drug Pricing Biosimilars Hospitals 98

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.

Drug Pricing 98

Drug Pricing Biosimilars 98

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.

Specialty Pharmacies 97

Specialty Pharmacies Drug Pricing Biosimilars 97

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.

Biosimilars 105

Biosimilars Drug Pricing 105

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.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

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.

Biosimilars 100

Biosimilars Drug Pricing 100

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.

Drug Pricing 53

Drug Pricing Biosimilars 53

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.

Biosimilars 59

Biosimilars Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

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.

Drug Pricing 100

Drug Pricing Biosimilars 100

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.

Drug Pricing 52

Drug Pricing Pharmaceutical Manufacturing Biosimilars 52

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.

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

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.

Drug Pricing 98

Drug Pricing Biosimilars 98

Pharmaceutical Technology

JANUARY 16, 2023

Untamed inflation is a top concern for the pharmaceutical industry globally in 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.

Drug Pricing 64

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 64

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.

Drug Pricing 98

Drug Pricing Biosimilars 98

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.

Biosimilars 58

Biosimilars Dosage Drug Pricing 58

FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

2140, the Patent Eligibility Restoration Act of 2023 (“ PERA Act ”). IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S.

Biosimilars 76

Biosimilars Drug Pricing 76

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.

Drug Pricing 98

Drug Pricing Biosimilars Compounding 98

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.

Drug Pricing 74

Drug Pricing Biosimilars 74

Pharmaceutical Technology

JANUARY 16, 2023

Untamed inflation is a top concern for the pharmaceutical industry globally in 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.

Drug Pricing 52

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 52

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.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

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. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. These new prices will take effect starting January 1, 2026.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

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

Drug Pricing 64

Drug Pricing 64

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.

Biosimilars 45

Biosimilars Drug Pricing 45

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.

Biosimilars 52

Biosimilars Pharmaceutical Manufacturing Drug Pricing Pharmaceutical Companies 52

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.

Drug Pricing 52

Drug Pricing Biosimilars 52

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.

Generic Medicine 98

Generic Medicine Drug Pricing Biosimilars Hospitals 98

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.

Vaccines 52

Vaccines Diabetes Drug Pricing Biosimilars 52

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. CMS will provide all manufacturers of Part B and Part D rebatable drugs the respective reports, even if their rebate amount due for an applicable period is $0.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Pricing 59

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.

Controlled Substances 40

Controlled Substances Drug Development Drug Pricing 40

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 ).

Drug Pricing 59

Drug Pricing 59