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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Biosimilars FDA Disease Drugs 294

Drugs.com

FEBRUARY 19, 2025

Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus. WEDNESDAY, Feb. 19, 2025 -- The U.S. Merilog is a rapid-acting human.

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Biosimilars FDA Approval FDA Drugs 147

Drug Patent Watch

MARCH 16, 2025

The Biosimilar Revolution: How It's Changing the Game for Biologic Drug Manufacturers As the pharmaceutical industry continues to evolve, one trend is gaining significant attention: the rise of biosimilars. In this article, we'll explore the impact of biosimilars on biologic drug life cycle management.

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Biosimilars Drugs Marketing Pharmaceuticals 52

Drug Patent Watch

OCTOBER 17, 2024

Regulatory Considerations for Biosimilar Analytical Similarity Assessments Biosimilars, or follow-on biologics, are biopharmaceuticals that are highly similar to an already approved biological product.

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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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Biosimilars Drugs Marketing 243

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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Biosimilars Marketing 144

BioPharma Drive: Drug Pricing

JULY 24, 2023

Despite setbacks with a Humira biosimilar, the partners have expanded an existing alliance, with Teva agreeing to purchase bonds while Alvotech pursues a stock sale.

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Biosimilars 130

BioPharma Drive: Drug Pricing

OCTOBER 2, 2024

Biosimilar competition to aging blockbusters will erode a large chunk of the pharma giant’s top line over the next few years.

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Biosimilars 269

Drugs.com

FEBRUARY 19, 2025

Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.Merilog is a rapid-acting human. WEDNESDAY, Feb. 19, 2025 -- The U.S.

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Biosimilars FDA Approval FDA Drugs 130

BioPharma Drive: Drug Pricing

OCTOBER 2, 2024

It’s the first time, according to the insurer, that this type of model has been used to bring a Humira biosimilar to market, and it yields a much lower cost than both the brand-name version of the drug and biologic copycats.

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Biosimilars Marketing Drugs 130

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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Biosimilars Clinical Trials Production Marketing 98

Drug Patent Watch

OCTOBER 16, 2024

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

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Biosimilars Drug Development Drugs Pharmaceuticals 113

ProRelix Research

JULY 6, 2023

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases. In […] The post Biosimilar clinical trials and study designs’ considerations appeared first on ProRelix Research.

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Clinical Trials Biosimilars Trials Treatment 105

Drug Patent Watch

JULY 22, 2024

In the rapidly evolving landscape of biosimilars, intellectual property (IP) strategy is paramount. Biosimilar manufacturers face unique challenges, including navigating […] Source

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Biosimilars 103

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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Biosimilars Drugs Pharmaceuticals Production 97

Drug Patent Watch

JULY 9, 2024

The introduction of biosimilars has significantly altered the landscape of biologic drug distribution models. Biosimilars, which are highly similar to […] Source

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Biosimilars Drugs 96

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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Biosimilars Marketing Drugs 196

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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Biosimilars Drugs Production Clinical Trials 90

Drug Patent Watch

JULY 11, 2024

In the high-stakes world of biosimilar development, manufacturers are increasingly turning to an unexpected partner: the Patent Trial and Appeal […] Source

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Biosimilars Trials 99

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 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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Biosimilars Pharmacy Marketing Pharmaceuticals 98

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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Biosimilars Marketing Drugs Production 98

BioPharma Drive: Drug Pricing

JULY 18, 2024

The German drugmaker will offer a 92% discount on a copycat version of Humira for people who pay cash for the drug through GoodRx.

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Biosimilars Drugs 190

BioPharma Drive: Drug Pricing

JULY 26, 2024

Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.

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Biosimilars FDA Drugs 167

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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Biosimilars Therapies Treatment Disease 96

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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Biosimilars Pharmaceuticals Treatment Production 95

BioPharma Drive: Drug Pricing

JANUARY 22, 2024

The divestment, which includes sales and reimbursement staff, is part of Coherus plan to shift resources toward its R&D work in oncology.

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Biosimilars 176

BioPharma Drive: Drug Pricing

APRIL 26, 2024

Prescription volume erosion is tracking with company forecasts, executives claimed, even as more insurers could exclude the branded drug.

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Biosimilars Drugs 184

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

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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Biosimilars Pharmacy Drugs Production 98

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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Biosimilars FDA Licensing Licensing 98

Drug Patent Watch

MARCH 31, 2024

A recent study published in JAMA Health Forum sheds light on the impact of biosimilar competition on patient out-of-pocket (OOP) costs for biologic drugs in the United States. The research,… Source

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Biosimilars Drugs Research 105

BioPharma Drive: Drug Pricing

JUNE 28, 2024

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

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Biosimilars Regulations Drugs Disease 167

Drug Channels

JANUARY 28, 2022

Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. Today’s guest post comes from Fiza Bari, Senior Solutions Consultant and GTM Liaison at MMIT.

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Biosimilars Marketing Drugs 98

BioPharma Drive: Drug Pricing

OCTOBER 23, 2024

With “nerves of steel,” Amgen is getting ready to sell a copycat of Regeneron’s top-selling eye drug Eylea, even as litigation continues.

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Biosimilars Drugs 157

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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Biosimilars Pharmacy Drugs Production 98

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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Biosimilars Pharmacy Production Drugs 98