FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. Karst & Michael D. Supreme Court declined to hold, in FTC v. Actavis, Inc. ,

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Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Drug Channels

SEPTEMBER 7, 2022

As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. In many therapeutic areas, biosimilars’ market share is approaching 80%. That’s when Humira, the best-selling drug in the U.S., will face multiple biosimilar competitors. d/b/a Drug Channels Institute.

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Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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Drug Channels

DECEMBER 17, 2020

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Drug pricing perceptions always seem to lag reality. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise.

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Drug Channels

FEBRUARY 7, 2023

As you've surely heard, Amgen has just launched Amjevita, the first non-interchangeable biosimilar of Humira. Our crazy drug channel led Amgen to launch both a high-list/high-rebate and a low-list/low-rebate version of the drug. d/b/a Drug Channels Institute. This Feed is for personal non-commercial use only.

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Drug Channels

SEPTEMBER 6, 2023

CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz.

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Drug Channels

APRIL 3, 2024

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. The 2024 formularies described below should boost biosimilar adoption. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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Drug Channels

OCTOBER 14, 2022

Today’s guest post comes from Steve Callahan, Senior Manager of Market Research at MMIT. Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. d/b/a Drug Channels Institute. d/b/a Drug Channels Institute. Read on for Steve’s insights.

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Drug Channels

MARCH 30, 2023

So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version. As you've surely heard, Amgen has just launched Amjevita, the first non-interchangeable biosimilar of Humira. d/b/a Drug Channels Institute. In February, AbbVie stated that U.S.

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Drug Discovery World

APRIL 13, 2023

Created by DDW and sponsored by Bio-Rad, The future of antibody-based drugs: Where are the opportunities and what does the future hold? is a free In Focus report, available here.

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Drug Channels

SEPTEMBER 13, 2022

Today, I want to highlight three significant—and presumably unintended—drug channel consequences from the hastily-passed IRA legislation. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc.

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Drug Channels

JULY 20, 2022

In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy. d/b/a Drug Channels Institute. P.S. Join my nearly 30,000 (!) to 1:30 p.m.

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BioPharma Drive: Drug Pricing

AUGUST 24, 2023

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

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Drug Channels

DECEMBER 12, 2022

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Today, I want to highlight three significant—and presumably unintended—drug channel consequences from the hastily-passed IRA legislation. d/b/a Drug Channels Institute. 117-169).

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Drug Channels

SEPTEMBER 8, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for his latest video webinar: Drug Channels Update: Buy-and-Bill Market Trends. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. d/b/a Drug Channels Institute. to 1:30 p.m.

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BioPharma Drive: Drug Pricing

APRIL 19, 2024

The agreement may help Alvotech capitalize on a recent policy shift by CVS that has driven major market share declines for AbbVie’s blockbuster drug.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. In the second category—limiting blockades to marketing—are efforts to limit blocking exclusivities and induced infringement liability.

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Drug Discovery World

JULY 24, 2023

The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. Yesafili (aflibercept), a biosimilar treatment of age-related macular degeneration.

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Drug Channels

AUGUST 16, 2024

Today’s guest post comes from Benjamin Hinton II, Senior Market Access Solutions Analyst at MMIT. Benjamin reviews the growing trend of PBMs vertically integrating into the production of biosimilars. The findings shed light on payers' view of biosimilar conpetition, contracting challenges, and other issues.

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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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Drug Discovery World

DECEMBER 21, 2023

The total sales of inflammatory bowel disease (IBD) drugs are estimated to reach approximately $10.2 The increase in IBD biologic treatments has been a major driving force in the growth of this market in recent years. Since then, the IBD market has seen the entry of seven biologics.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.

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The Pharma Data

MARCH 22, 2023

As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” said Keren Haruvi, President, Sandoz Inc., Head of North America. “As

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Drug Channels

JUNE 27, 2021

As you declare your vaccinated independence, celebrate with these Drug Channels fireworks: Amazon’s teeny step toward pharmacy disruption How patients view copay accumulators My $0.02 on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing.

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Drug Channels

MARCH 5, 2024

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s latest live video webinar: Drug Channel Implications of the Inflation Reduction Act This event will be broadcast live on Friday, April 5, 2024, from 12:00 p.m. to 1:30 p.m. All rights reserved.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Drug Channels

MAY 29, 2024

Register now for The 340B Drug Pricing Program: Trends, Controversies, and Outlook , a new live video webinar with Adam J. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Summer unofficially began over the weekend. Join my nearly 56,000 LinkedIn followers for daily links to neat stuff.

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Drug Discovery World

SEPTEMBER 23, 2022

The Fall Issue of the Drug Discovery World Magazine is out now. . Key features of the Fall Issue include How AI in Pharma Can Live Up to the Hype, insight into drug repurposing and Moderna explains how mRNA technology may hold the future for a cytomegalovirus vaccine. . UK’s Drug Discovery 2022 in London, October 4-5, 2021.? .

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Drug Discovery World

SEPTEMBER 22, 2022

The modified-release budesonide capsules have been designated an orphan medicinal product qualifying for 10-year market exclusivity. The drug was developed in collaboration with Calliditas Therapeutics, and will be marketed in Europe by STADA Arzneimittel, with the first launch in Germany.

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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. Dr. Adam J.

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Drug Discovery World

OCTOBER 20, 2022

DDW Multimedia Editor Megan Thomas takes a broad look at the drug discovery and development landscape in Japan and highlights how it is bolstered by government policies, investment, collaboration, start-up ecosystems and academic research. . Similarly, biosimilars are expected to grow. Similarly, biosimilars are expected to grow.

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Drug Patent Watch

JUNE 3, 2021

Get Your Certificate Today By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay…. The post Get Your Certificate in Generic and Branded Drug Lifecycle Management appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT.

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BioPharma Drive: Drug Pricing

JULY 26, 2023

In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.

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The Pharma Data

JULY 28, 2021

billion across its major markets in 2020 alone. These major markets represented 75% of Teva’s revenues in 2020. Across 9 major markets in Europe, Teva saved healthcare systems $9.6 biosimilars market continues to develop, savings are expected to grow and surpass $100 billion from 2020 to 2024. billion in 2020.

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Drug Channels

JULY 23, 2024

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. 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. You can find links to each company’s data below.

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