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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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

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

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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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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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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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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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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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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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

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

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 Discovery World

AUGUST 22, 2023

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. Complex generics comprise a diverse range of products.

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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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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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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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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 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

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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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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Drug Channels

DECEMBER 17, 2020

Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. d/b/a Drug Channels Institute.

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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 Discovery World

MAY 5, 2023

Biosimilars now account for 25% of total volume of the relevant molecules, although there is wide variation in uptake due to differences in strategies adopted by originator and biosimilar manufacturers, payer and PBM decisions, as well as clinician and patient preferences.

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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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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

AUGUST 16, 2024

Benjamin reviews the growing trend of PBMs vertically integrating into the production of biosimilars. The findings shed light on payers' view of biosimilar conpetition, contracting challenges, and other issues. Click here to learn more about MMIT’s Custom Market Research offering for biosimilar manufacturers.

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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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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. You should not place undue reliance on these statements.

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Drug Discovery World

JULY 24, 2023

The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. Yesafili (aflibercept), a biosimilar treatment of age-related macular degeneration.

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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability. Biogen Inc.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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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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FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

Instead, many of these actions are essentially claim breach of warranty, in which consumers allege that they would not have purchased products at issue if the presence of PFAS had been more clearly noticed. Those claims are often triggers for plaintiff’s litigation if used with products that contain PFAS. By John W.M.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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Drug Discovery World

OCTOBER 3, 2022

Product Manager at SPT Labtech, for a fascinating deep dive into the practical considerations of how, when and why you should automate your laboratory’s liquid handling processes. How can automation help the discovery of biologics and biosimilars? Join Anne Hammerstein, Ph.D., The sustainable lab. The automated lab and the human.

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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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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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