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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Biosimilars 183

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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Biosimilars 169

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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Biosimilars FDA Regulations Drugs 161

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 287

Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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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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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

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

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

Drug Patent Watch

APRIL 1, 2025

The Biosimilar Revolution: How Europe's Generic Drug Industry is Evolving As we navigate the ever-changing landscape of the pharmaceutical industry, one trend is clear: biosimilars are here to stay. In Europe, the generic drug industry is undergoing a significant transformation, driven by the increasing adoption of biosimilars.

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Biosimilars Marketing Drugs Government 78

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

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

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 264

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 141

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 112

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

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Biosimilars Trials Clinical Trials Production 55

Drug Patent Watch

MARCH 13, 2025

Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

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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 102

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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Drug Channels

DECEMBER 9, 2024

During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state. As you will see below, CVS Healths formulary actions led to rapid uptake of a low-list-price biosimilar.

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Biosimilars Production Marketing Drugs 52

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 95

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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Biosimilars Pharmacy Marketing Drugs 98

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 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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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 97

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

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 189

Drug Patent Watch

MARCH 5, 2025

The Future of Diabetes Care: How Biosimilar Insulin Products Are Revolutionizing Treatment As we continue to navigate the ever-evolving landscape of diabetes care, one thing is clear: innovation is key. And when it comes to insulin therapy, a game-changing trend is emerging: biosimilar insulin products.

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ProRelix Research

MAY 23, 2025

As the patents for blockbuster biologics expire, a new era of opportunity emerges, ushering in the rise of biosimilars.

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Biosimilars Clinical Trials Marketing Trials 52

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 95

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 183

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 94

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 161

Drug Patent Watch

MARCH 20, 2025

Navigating the Complex World of Biosimilar Regulatory Agency Interactions As a biosimilar developer, you know that getting your product to market can be a long and arduous process. By following these strategies, you can build strong relationships with regulatory agencies and set your biosimilar product up for success.

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