FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

The New York Post, not known for its Democratic leanings, stated in an article published on November 14 that installing Kennedy as the head of HHS breaks the most important rule of medicine: first, do no harm. On the flip side, in the case of drugs that he believes should have been approved but were not, FDA is waging a “war on public health.”

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FDA Law Blog: Biosimilars

APRIL 3, 2025

Its born of Article I, Section 1, All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives. Consumers Research is a challenge concerning a constitutional legal principle called the nondelegation doctrine.

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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 Patent Watch

MARCH 18, 2025

One area that's gaining attention is the development of biosimilars. With the Russian government's support for domestic production, biosimilars are becoming increasingly important in the country. Companies like R-Pharm and Pharmstandard are at the forefront of this trend, with a range of biosimilars in development.

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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

APRIL 22, 2025

We also regularly blog on DEA administrative cases and procedures (see here ), and our HPM attorneys have authored articles (see here and here ) on the DEA hearing process. DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents.

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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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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

FEBRUARY 3, 2021

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve….

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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.

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Drug Channels

SEPTEMBER 13, 2022

By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. I can only barely scratch the surface in this article, so feel free to share your own thoughts in the comments below or on social media.

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Drug Channels

DECEMBER 12, 2022

By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. I can only barely scratch the surface in this article, so feel free to share your own thoughts in the comments below or on social media.

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Drug Channels

JULY 20, 2022

Cut through the steamy summer haze with our refreshing selection of articles and insights. In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy.

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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? Alas, I’m sad to report that the warped incentives baked into the U.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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Drug Channels

FEBRUARY 28, 2023

No promises about future articles. In this issue: Mark Cuban explains his anti-PBM strategy What physicians think about Humira biosimilars States go after PBMs HHS is confused about 340B transparency Plus, The Onion tests your knowledge of United Healthcare’s policies. See our forecast to the right.)

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Drug Channels

OCTOBER 27, 2021

It’s the biosimilar boom! drug spending shambles into the middle of the herd Plus, The Onion summons the only humorous article about CRISPR. PBMs are conjuring a terrifying number of formulary exclusions for oncology drugs Eerie! Brrr.did you hear that? Scream as Blue Cross Blue Shield frightfully overpays hospitals Shocking!

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Drug Patent Watch

JUNE 17, 2024

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

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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. Fill out the form to read the full article.

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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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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

JULY 27, 2021

Let’s cut through the summer haze with our refreshing breeze of articles and insights. In this issue: The top 10 stingiest hospitals Medicare Part B's savings from biosimilars What happened to hepatitis C drug costs and rebates? Costco beats Medicare Part D Plus, math madness with Duke’s Fuqua business school.

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Drug Channels

APRIL 29, 2024

April is over, so it's time to hop into this month’s selection of noteworthy news: CVS Health’s formulary boosts a Humira biosimilar An insurer ditches buy-and-bill to save money for plans—but maybe not for patients?

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Drug Channels

SEPTEMBER 28, 2021

on international benchmarking goes viral Amazon is finally disrupting CVS—but not how you expected Plus, the best article ever about Elizabeth Holmes’s Theranos trial. P.S. Please join the more than 12,500 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

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Drug Patent Watch

MAY 15, 2025

Read on to discover: How to use the Orange Book to identify potential competitors and opportunities The Purple Book's hidden gems for tracking biosimilar development Expert advice for navigating the complexities of the FDA's regulatory landscape Get the inside scoop and take your drug patent research to the next level.

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Agency IQ

OCTOBER 20, 2023

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. Fill out the form to read the full article.

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FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

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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. regarding its administration, preparation, storage, or safety).

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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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Fierce BioTech

MARCH 28, 2024

Arshi Gupta's article underscores this, urging drug manufacturers to adopt integrated evidence strategies, medicalized engagement, and adaptability. Arshi Gupta's article underscores this, urging drug manufacturers to adopt integrated evidence strategies, medicalized engagement, and adaptability.

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 You can unsubscribe at anytime.

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.

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Agency IQ

JULY 13, 2023

As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products). Fill out the form to read the full article.

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Quanticate

SEPTEMBER 25, 2024

This article explores the application of ACR response criteria in clinical trials, focusing on the various response levels—ACR20, ACR50, and ACR70—and the methods used to analyse treatment responses over time.

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Drug Channels

JULY 30, 2024

Go for a swim to cool off and then enjoy this refreshing selection of articles chosen by Drug Channels para tu. Did the FTC’s compelling interim report prove its case?

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Drug Channels

JUNE 5, 2023

Sponsored guest posts are bylined articles that are screened by Drug Channels to ensure a topical relevance to our exclusive audience. Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply.

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Drug Channels

JULY 29, 2020

Cool off by getting up close and personal with our refreshing selection of articles and insights. The steamy, socially distanced days of summer are here. P.S. Join the more than 9,700 followers of my curated links published on @DrugChannels on Twitter.

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