Biosimilars, Books and Regulations - Drug Discovery Digest

The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.

Pharmaceutical Companies

Pharmaceutical Companies FDA Production Regulations

Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law Blog: Biosimilars

MAY 15, 2025

Many of the Commissioners comments were familiar to those who have followed his podcasts and book rounds: he firmly believes the FDAs regulatory model needs disruption. Beyond regulatory work, the Commissioner ventured into what he called crossing into advocacy, especially relating to food regulation.

FDA

FDA Vaccine International Disease

ACI’s 21st Annual Paragraph IV Disputes

FDA Law Blog: Biosimilars

MARCH 12, 2025

Raimondo Exploring the On-Sale Bar and Applicability of Prior Art Orange Book Delisting Attempts Navigating ODP and Patent Family Dynamics Hyman, Phelps & McNamara, P.C.s FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

FDA

FDA Regulations Pharmaceuticals Drugs

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog: Biosimilars

JUNE 13, 2024

Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. And on X (R.I.P.

FDA

FDA FDA Approval Production Drugs

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

FDA

FDA Drugs Biosimilars FDA Approval

FTC Continues to Rage Against Device Patent Listings in the Orange Book

FDA Law Blog: Biosimilars

MARCH 26, 2024

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book. Because a “drug product” is defined by regulation as a “Finished dosage form.

FDA

FDA Production FDA Approval Drugs

FDA Knows Its Own Strength—and It Includes Concentration

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.,

FDA

FDA Biosimilars Production Regulations

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

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).

Biosimilars

Biosimilars Science FDA Licensing

Drugs Companies Clap Back at Congress…Then Get Sued

FDA Law Blog: Biosimilars

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

Drugs

Drugs FDA Regulations FDA Approval

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

Article FDA Thank You For first time, FDA releases OTC drug user fees prior to start of government fiscal year

Agency IQ

SEPTEMBER 15, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 11, 2023 6:44 PM CDT Regulatory background: User fees and over-the-counter (OTC) drug reform Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably. Read AgencyIQ analysis here.]

FDA

FDA Government Drugs Production

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

Government

Government FDA Biosimilars Regulations

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

FDA

FDA Science Biosimilars Clinical Trials

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Food and Drug Administration (FDA). 2,3 In the U.S.,

Clinical Trials

Clinical Trials Treatment Therapies Production

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog: Biosimilars

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. But it is too early to tell whether this or any other SIP that FDA authorizes will succeed in reducing the price of the imported drugs.

FDA Approval

FDA Approval FDA Drugs Licensing

Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

The Pharma Data

MAY 3, 2021

An FDA official who led the approval of OxyContin got a $400,000 gig at Purdue Pharma a year later, a new book reveals ( BI ). Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ).

Vaccine

Vaccine Biosimilars FDA Regulations

Saving the Skinny Label Through the Skinny Label, Big Savings Act

FDA Law Blog: Biosimilars

JANUARY 1, 2025

More specifically, the bill states that these activities shall not be acts of direct, induced, or contributory infringement of a method of use claim in a patent listed in the Orange Book. The safe harbor applies only when the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent.

Biosimilars

Biosimilars Regulations FDA Drugs

Drug Discovery Digest

The Issue with Reissue: PTE Edition

Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

Trending Sources

ACI’s 21st Annual Paragraph IV Disputes

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FTC Continues to Rage Against Device Patent Listings in the Orange Book

FDA Knows Its Own Strength—and It Includes Concentration

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Drugs Companies Clap Back at Congress…Then Get Sued

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Article FDA Thank You For first time, FDA releases OTC drug user fees prior to start of government fiscal year

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

Saving the Skinny Label Through the Skinny Label, Big Savings Act

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