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labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.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

MARCH 18, 2025

The question is important because the result of that determination could drastically reduce the amount of patent term to be restored.

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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 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

The ideal candidate will have a book of business. Strong verbal and writing skills are required. Partner/director, counsel and senior associate level attorneys with the requisite substantive experience are encouraged to apply. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer.

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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.

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

For the 40th anniversary of the Orange Book (and the quasi-35th anniversary of Hatch-Waxman), we put together a public Orange Book Archive (and it has become one of the more popular stops on the FDA Law Blog). For the 25th and 30th anniversaries, we held trivia contests ( here and here ).

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FDA Law Blog: Biosimilars

JULY 24, 2024

Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act. s Kurt R.

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Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests required for covered OTC products to be generally recognized as safe and effective (GRASE). Read AgencyIQ analysis here.]

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Agency IQ

JULY 8, 2024

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

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Agency IQ

MARCH 1, 2024

For example, statutorily, the prescription drug user fee program (PDUFA) has a statutory cap of total carryover for operating reserves of 14 weeks, while the biosimilar user fee program (BsUFA) had a goal of bringing the carryover balance down to “no greater than 21 weeks of operating reserves” by the end of the 2022 fiscal year.

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Agency IQ

OCTOBER 6, 2023

There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

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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. However, additional naloxone products will remain prescription drugs. Additionally, 8 mg naloxone nasal spray (N212045) is also still a prescription drug.

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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

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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. Its a brandthe greatest in the world, he saidand he thinks that change is needed to live up to that lofty reputation.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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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.

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FDA Law Blog: Biosimilars

MAY 11, 2023

Where the generic sponsor has carved-out the specific indication identified in the Orange Book as covered by the method of use patent, the Government argues, the generic labeling “cannot provide the requisite evidence of specific intent to induce infringement.”

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The Pharma Data

MAY 6, 2021

The group said that “it is a good time to brush up on potential for the Biden administration to use the Defense Production Act to loosen up access to manufacturing know-how and access to working cell lines and ask the WHO what its procedures are for evaluating quality of generic/biosimilar vaccines.”. .

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The Pharma Data

FEBRUARY 8, 2021

price, patients switching to Toujeo ® and biosimilar glargine competition. to €189 million) reflecting recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition in several European countries. Full-year 2020 franchise sales were down 4.8%

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The Pharma Data

FEBRUARY 4, 2021

price, patients switching to Toujeo ® and biosimilar glargine competition. to €189 million) reflecting recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition in several European countries. Full-year 2020 franchise sales were down 4.8%

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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.

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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. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. Food and Drug Administration (FDA).

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The Pharma Data

APRIL 7, 2023

Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. Am Soc Clin Oncol Educ Book. Updated November 17, 2022. Accessed February 2, 2023. 2019;39:207-215.

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FDA Law Blog: Biosimilars

MAY 28, 2025

Jazz holds a patent that does not cover Xyrem or Xywav and, therefore, is not listed in the Orange Book. The decision leaves open a question posed by Avadel: whether a 505(b)(2) submission is an artificial act of infringement under 271(e)(2) if there was no Orange Book patent certification.

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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.

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

First, the Tropical Disease PRV program is the oldest one on the books and was the only one that was drafted without a sunset clause. While lapse of this program may raise concerns about the end of the Tropical Disease PRV, such a result is highly unlikely.

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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.

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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 ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). Medtech.

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