Biosimilars, Books and FDA Approval - Drug Discovery Digest

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.

FDA

FDA Production FDA Approval Drugs

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promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

Biosimilars

Biosimilars Science FDA Licensing

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” FDA thus disagrees that such differences are not clinically meaningful.

FDA

FDA Biosimilars Production Regulations

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

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

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The user fee program for OTC drugs is relatively young. Read AgencyIQ analysis here.]

FDA

FDA Government Drugs Production

2023 IS the Year for OTC Naloxone!

FDA Law Blog: Biosimilars

MARCH 29, 2023

The OTC approval of NNS will not change the prescription status of the 21 injectabl e naloxone products listed in the Orange Book. Today’s OTC naloxone approval is limited to NNS specifically, but we are aware of other OTC naloxone applications currently being reviewed by FDA. launch would be in early 2024.

Pharmacy

Pharmacy FDA FDA Approval Production

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

FY 2023 saw the largest number of novel biologic products approved in a single fiscal year. There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA

FDA Biosimilars Science Drugs

Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

MAY 11, 2023

If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.” No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.”

Government

Government FDA FDA Approval Doctors

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Am Soc Clin Oncol Educ Book.

FDA

FDA FDA Approval Small Molecule Drugs

What’s in a Claim? The Federal Circuit Rules on Orange Book Patent Listings

FDA Law Blog: Biosimilars

JANUARY 8, 2025

Koblitz Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing. Nine patents are listed in the Orange Book with ProAir HFA.

Production

Production FDA FDA Approval Drugs

Injunction Junction, What’s Your Function under the Patent Safe Harbor?

FDA Law Blog: Biosimilars

MAY 28, 2025

Specifically, the District Court enjoined Avadel from (1) offering open-label extensions to clinical trial participants, (2) applying for FDA approval of Lumryz for idiopathic hypersomnia, and (3) initiating new clinical trials or studies after the Courts Order. Avadels product was approved as a 505(b)(2) referencing Xyrem.

Clinical Trials

Clinical Trials FDA Approval FDA Trials

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. More Steps Ahead As the SIP sponsor, Florida will be responsible for implementing the program. See 21 C.F.R. 251.5; § 251.6(c).

FDA Approval

FDA Approval FDA Drugs Licensing

Drug Discovery Digest

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

Trending Sources

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

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

FDA Knows Its Own Strength—and It Includes Concentration

Drugs Companies Clap Back at Congress…Then Get Sued

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

2023 IS the Year for OTC Naloxone!

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Skinny Label and Induced Infringement: The Saga Continues

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

What’s in a Claim? The Federal Circuit Rules on Orange Book Patent Listings

Injunction Junction, What’s Your Function under the Patent Safe Harbor?

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

Stay Connected