FDA Law Blog: Biosimilars

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). This all sounds complicated, I know.

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The Premier Consulting Blog

AUGUST 8, 2024

As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024). FDA-2023-N-2850. July 28, 2023. FDA-2024-N-0007. July 31, 2024. [ii] ii] United States Federal Register. 88 FR 48881.

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Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

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Agency IQ

JANUARY 12, 2024

CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals According to a report released this week describing CDER’s approval of 55 novel drugs in 2023, the agency failed to meet its goal dates under the Prescription Drug User Fee Act (PDUFA) Commitment Letter for 11% of applications – a record high.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Agency IQ

JULY 8, 2024

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). as early as July 2023 in accordance with the terms of its agreement with AbbVie. Pfizer Inc.

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Agency IQ

MAY 3, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions. The following PDUFA dates were obtained from publicly available sources.

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Drug Target Review

FEBRUARY 1, 2024

Two recent transactions both occurring in Q4 2023 prove this point. The organizing principle is the data package. We were able to license a molecule from a multi-national pharmaceutical company. Every constituency in our ecosystem is rooting for success, and when it happens you see folks lean in; strategic and investors alike.

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Codon

FEBRUARY 13, 2024

Fast forward to 2023. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. At least a million people die from drug-resistant bacterial infections every year.

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Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC, LAURA DIANGELO, MPH MAY 30, 2023 9:39 PM CDT Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely. OIRA eventually released the rule for release by the FDA (with changes) on May 10, 2023.

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Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. The following PDUFA dates were obtained from publicly available sources. and the E.C.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. The Fall 2022 edition was released in January 2023. June 2023 may be a busy month for the agency.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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DrugBank

NOVEMBER 7, 2023

EDMONTON, CANADA, November 1st, 2023— DrugBank today kicked off their role as a key distributor of the American Society for Health-System Pharmacists’s (ASHP) data. The healthcare community can license ASHP data for use in new or existing software, databases, or websites in formats specific to organisational needs.

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Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. What is the microbiome itself?

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Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

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Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

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Agency IQ

JANUARY 12, 2024

The supply chain could only contain three entities: The manufacturer, the Foreign Seller (who must also be a licensed wholesaler by Health Canada), and the importer. label for that product, including patient labeling such as Medication Guides and patient package inserts.

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FDA Law Blog: Biosimilars

DECEMBER 14, 2023

The governors (of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York) thanked the President for his leadership in directing the Department of Health and Human Services (“HHS”) to reconsider the current scheduling of cannabis and HHS’ August 2023 rescheduling recommendation to the Drug Enforcement Administration (“DEA”).

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Drug & Device Law

JULY 31, 2023

2023 WL 2655586, at *3 (Cal. March 10, 2023) (quoting relevant §19(a) language); Flores v. Jacobs , 2023 WL 2655586, at *4. 2023 WL 2638314, at *4 (C.D. 20, 2022) (quoting Anthony ), reconsideration denied , 2023 WL 3321752 (C.D. March 9, 2023). 2023 WL 2986797, at *5 (Conn. April 14, 2023); Nazar v.

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Drug & Device Law

JANUARY 4, 2024

FDA letter , December 14, 2023 (by Peter Marks, director CBER) (emphasis original). The “result” alleged was that “[a]s of November 10, 2023, Texans have been administered almost 30 million. . . 2023) (finding defendant’s vaccine to be a covered countermeasure; preempting all claims), review denied (Kan. 25, 2023); Goins v.

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Drug & Device Law

MAY 22, 2023

On May 4, 2023, Montana’s governor signed Senate Bill 216 into law, and it enacted a number of measures intended to restore some balance to product liability lawsuits in Big Sky Country. Montana has also limited third-party bad faith lawsuits against insurers, which even plaintiff-friendly California banned more than 30 years ago.

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Drug & Device Law

MAY 15, 2023

2d , 2023 Wisc. May 2, 2023), and M.T. 3d , 2023 WL 3135662 (Kan. April 28, 2023). 2023 WL 3135662, at *3-5 (detailed PREP Act discussion). 2023 WL 3135662, at *1 (quoting complaint). They are: Gahl v. Aurora Health Care, Inc. LEXIS 137 (Wis. Walmart Stores, Inc. , 247d-6d(b). pharmacist. . . E.g. , M.T.

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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