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

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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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

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.

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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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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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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

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. Another significant challenge is the high cost of development.

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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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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

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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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

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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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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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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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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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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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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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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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. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S.

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Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. By Riëtte van Laack & Anne K. What led to this conviction? It is a long story that started more than a decade ago.

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ProRelix Research

NOVEMBER 23, 2022

Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […]. The post Biosimilar Clinical Trials and US FDA Guidance appeared first on ProRelix Research.

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Drug Channels

APRIL 3, 2024

The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation.

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Drug Channels

FEBRUARY 21, 2024

Like many of you, I have believed that the Inflation Reduction Act of 2022 (IRA) will encourage Medicare Part D plans to adopt low-list-price products over their high-list/high-rebate counterparts, thereby popping the gross-to-net bubble. Just another IRA-inflicted hit for biosimilars? Actually, maybe not.

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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

JANUARY 19, 2022

Each exclusion list contains 400 to 500 products. Below, I highlight five observations about this year’s lists, including unexplainable differences in how PBMs handle specialty drugs, biosimilars, and insulin. I also offer some thoughts on non-medical switching and what we still don’t know about how exclusions affect patients.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, 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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The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”

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FDA Law Blog: Biosimilars

JUNE 25, 2024

Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. But, as time has marched on and FDA’s experience with interchangeable biosimilars grown, the Agency’s “experience has shown that.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms 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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Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

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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 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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