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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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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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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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.

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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. Another significant challenge is the high cost of development.

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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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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

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. Some—but likely not all—of these products will have interchangeability with Humira.

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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 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

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. But how can you ensure that these interactions are effective and set your product up for success?

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Drug Channels

JANUARY 10, 2023

Each exclusion list now contains about 600 products. Below, I highlight four takeaways from this year’s lists, including a look at biosimilar insulin and the forthcoming biosimilar competition for Humira. I also note some troubling research on the patient impact of exclusions—although much remains unknown.

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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 Patent Watch

APRIL 2, 2025

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives.

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Drug Channels

MARCH 28, 2023

Each exclusion list now contains about 600 products. Below, I highlight four takeaways from this year’s lists, including a look at biosimilar insulin and the forthcoming biosimilar competition for Humira. I also note some troubling research on the patient impact of exclusions—although much remains unknown.

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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. Read on for my deep dive into these two therapeutic categories.

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The Pharma Data

JULY 3, 2025

Sunshine Biopharma Launches NIOPEG® Biosimilar in Canada, Targeting $10B Biologics Market Sunshine Biopharma Inc. and marks Sunshine Biopharma’s entry into the rapidly expanding global biologics and biosimilars market. The global market for NEULASTA® and its biosimilars is substantial. In 2024, it was valued at approximately $4.5

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Drug Patent Watch

MARCH 18, 2025

The Russian pharma market has experienced significant growth in recent years, driven by a combination of factors, including government support, increasing healthcare spending, and a focus on domestic production. One area that's gaining attention is the development of biosimilars. billion by 2025, with a CAGR of 10.5%.

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Drug Channels

APRIL 1, 2025

As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace. For 2025, the Big Three PBMs shifted national formularies to favor their private-label biosimilars over Humira and its many biosimilar competitors. What do you think?

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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

APRIL 9, 2025

Just spent the day diving into the world of biosimilars and regulatory considerations. Key takeaways from the article on DrugPatentWatch: Biosimilar extrapolation of indications is a complex process that requires a deep understanding of the regulatory landscape.

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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

OCTOBER 15, 2024

Biosimilar competition is expected in early January for the company’s second highest-selling drug, putting greater focus on newer products' market trajectory.

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Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Drugs requiring specialized equipment, complex formulations, or intricate production methods are less likely to face immediate generic competition.

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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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Drug Channels

APRIL 19, 2022

An ironic postcript: Less than two months after my article was published, Cigna CEO David Cordani bragged about the cost savings from "aggressive adoption" of biosimilars. Anyone want to tell him about the Express Scripts formulary for insulin biosimilars? Read the FDA’s press release. drug channel problems will remain.

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Drug Channels

NOVEMBER 9, 2021

The Food & Drug Administration (FDA) recently approved the first interchangeable biosimilar insulin product: the insulin glargine-yfgn injection from Viatris. Viatris is being forced to launch both a high-priced and a low-priced version of the biosimilar. Read the FDA’s press release. drug channel problems will remain.

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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. d/b/a Drug Channels Institute.

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Drug Patent Watch

APRIL 8, 2025

Product Pipeline : A robust product pipeline can drive growth and increase a company's valuation. Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs.

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Drug Channels

SEPTEMBER 4, 2024

The Humira biosimilar market just took another step forward—but remains far from its ideal state. Last week, Cigna’s Express Scripts announced that it that will follow CVS Health’s CVS Caremark business and remove Humira from its largest commercial formulary in favor of multiple biosimilars.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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thought leadership

MAY 29, 2025

The document, entitled Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications , applies to human drug applications and biosimilar biological product applications.

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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. When finalized, this will supersede recommendations from a 2021 Q&A guidance.

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The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

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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. Fill out the form to read the full article.

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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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FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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