Drug Patent Watch

NOVEMBER 20, 2024

The pharmaceutical industry is constantly evolving, and one of the most exciting areas of growth is the development of biosimilars. These biological products, designed to be highly similar to existing approved biologics, offer the promise of more affordable treatment options for patients.

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Drug Patent Watch

AUGUST 15, 2023

A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs.

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Drugs.com

AUGUST 25, 2023

Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug. 25, 2023 -- The U.S.

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DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

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Drugs.com

AUGUST 25, 2023

Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug. 25, 2023 -- The U.S.

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Drug Patent Watch

FEBRUARY 3, 2021

Abstract Biosimilar medicines expand the biotherapeutic market and improve…. The post The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA appeared first on DrugPatentWatch - Make Better Decisions.

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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%. will face multiple biosimilar competitors. Prices are dropping while adoption accelerates. I also offer some thoughts on 2023 and 2024.

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Drug Channels

JANUARY 9, 2024

This year, Humira and its 13 biosimilars will provide the most intriguing formulary drama. Unfortunately, the gross-to-net bubble will remain a fixture for this category, despite a price war led by almost half of the biosimilars.

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Drug Channels

JANUARY 10, 2023

Below, I highlight four takeaways from this year’s lists, including a look at biosimilar insulin and the forthcoming biosimilar competition for Humira. Growth in the number of excluded drugs slowed for the second year, due partly to the fact that so many drugs have already been dropped from PBMs’ formularies.

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Drug Channels

MARCH 28, 2023

Below, I highlight four takeaways from this year’s lists, including a look at biosimilar insulin and the forthcoming biosimilar competition for Humira. Growth in the number of excluded drugs slowed for the second year, due partly to the fact that so many drugs have already been dropped from PBMs’ formularies.

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Drug Channels

OCTOBER 3, 2023

Since I published the article below in July 2023 , there have been three notable market develpoments: IQVIA has reported that as as of mid-2023, there was almost no adoption of Amgen's Amjevita, the first Humira biosimilar. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar.

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Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. Net prices in therapeutic classes with biosimilar competition have declined by 60% or more over the past few years. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. drug distribution.

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BioPharma Drive: Drug Pricing

DECEMBER 3, 2024

The company reached a deal to divest its third biosimilar this year, selling a copycat version of Amgen’s Neulasta for up to $558 million.

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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.

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Drug Patent Watch

NOVEMBER 5, 2024

The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.

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Drug Patent Watch

DECEMBER 9, 2024

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. link] KBDNA. 2024, May 17). link] Lawless, L.

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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. Its strategy echoes the pricing of the first interchangeable insulin biosimilars— as I predicted in 2021. Unfortunately, we should expect most PBMs and plan sponsors to embrace the high-list/high-rebate version.

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Drug Channels

DECEMBER 12, 2022

These include disruption to the now-booming biosimilar market, the prospects of physician/hospital vertical integration that will raise commercial healthcare costs and expand 340B, and the need for complex new processes to administer the IRA's lower pharmacy reimbursements.

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BioPharma Drive: Drug Pricing

JUNE 15, 2023

The biosimilar developer’s plans to set steep discounts on its copycat version of AbbVie’s Humira set off a legal back-and-forth between the companies.

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FDA Law Blog: Biosimilars

JULY 29, 2024

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.

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BioPharma Drive: Drug Pricing

APRIL 17, 2024

The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.

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Drug Channels

OCTOBER 14, 2022

Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. Today’s guest post comes from Steve Callahan, Senior Manager of Market Research at MMIT. To learn more, check out MMIT’s Strategic Launch Report & Evaluate Forecast solution. Read on for Steve’s insights.

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Drug Channels

DECEMBER 11, 2023

One update: CVS Caremark's 2024 formulary for patient-administered autoimmune products prefers: Humira Hyrimoz (the high WAC Sandoz biosimilar) adalimumab-adaz (the unbranded, low WAC Sandoz biosimilar) Perhaps coincidentally, Sandoz products are marketed by Cordavis, the new business described in today's rerun.

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Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

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BioPharma Drive: Drug Pricing

SEPTEMBER 20, 2023

The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.

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Drug Channels

NOVEMBER 4, 2024

Here on Drug Channels , we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars.

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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. In February, AbbVie stated that U.S.

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Drug Channels

SEPTEMBER 13, 2022

These include disruption to the now-booming biosimilar market, the prospects of physician/hospital vertical integration that will raise commercial healthcare costs and expand 340B, and the need for complex new processes to administer the IRA's lower pharmacy reimbursements.

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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

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. Cut through the steamy summer haze with our refreshing selection of articles and insights.

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ProRelix Research

MARCH 1, 2024

Biologicals products occupy a significant place in the treatment landscape of several autoimmune diseases and cancers and are most often the only choice of treatment and management of several diseases […] The post Biosimilars and Their Growing Importance in Healthcare appeared first on ProRelix Research.

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BioPharma Drive: Drug Pricing

MAY 13, 2024

As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.

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Drug Channels

SEPTEMBER 24, 2024

Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you: Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble Optum Rx joins the private label biosimilar bandwagon Biosimilars boom for provider-administered drugs Fresh evidence of how copay accumulators (..)

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Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Drug Channels

OCTOBER 31, 2023

CVS Health frightens all but one Humira biosimilar maker away from its formulary. It's time for a super-sized Halloween roundup of wicked Drug Channels ’ tales. This month’s tricks and treats: Spooky! The gross-to-net bubble for anti-obesity GLP-1 drugs walks among us. Penn Medicine gorges on the 340B program. Vampiric!

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Agency IQ

APRIL 26, 2024

BY RACHEL COE, MSC The FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

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Drug Channels

SEPTEMBER 24, 2024

Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you: Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble Optum Rx joins the private label biosimilar bandwagon Biosimilars boom for provider-administered drugs Fresh evidence of how copay accumulators (..)

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