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). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! We provide updated, expanded, and reorganized data about the following markets: Pharmacy services administrative organizations (Section 2.2.4.)

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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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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”.

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Drug Channels

FEBRUARY 22, 2022

As always, we have updated all market and industry data with the most current information available, including our annual analyses of the market positions of the largest pharmacies, specialty pharmacies, and PBMs. We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

While that’s not to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market impact, or to show that some of the promises of significant savings for large numbers of consumers have been realized.

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Drug Discovery World

MAY 1, 2023

The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified. The EC also proposes to abolish (in most cases) marketing authorisation renewal and introduce simpler procedures for generic medicines.

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Drug Channels

SEPTEMBER 12, 2023

As always, we have updated all market and industry data with the most current information available. The report also updates our annual analyses of the strategies, market positions, and executive compensation of the three largest companies: AmerisourceBergen (Cencora), Cardinal Health, and McKesson. d/b/a Drug Channels Institute.

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The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. . CAMBRIDGE, Mass. and TOKYO, Oct. Since October 2017 Biogen and Eisai Co.,

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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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

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Eight products received recommendations for conditional marketing authorization and one product was reviewed “under exceptional circumstances.” Reviews of orphan medicines and biosimilars have remained stable over the past three years.

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Drug Channels

FEBRUARY 21, 2023

As always, we have updated all market and industry data with the most current information available, including our annual analyses of the market positions of the largest pharmacies, specialty pharmacies, and PBMs. If you have any questions before purchasing a license to the report, please email me. d/b/a Drug Channels Institute.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. That was the case in the PTO’s April 3, 1995 decision denying a PTE as to U.S. Lehman , No.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA. The notification requirements apply to each individual manufacturer regardless of market share, the number of competitors making therapeutically equivalent products, or the amount of product in distribution.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA).

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Agency IQ

SEPTEMBER 22, 2023

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) – and includes prescribing information (PI).

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FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

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The Pharma Data

JANUARY 24, 2021

About Toripalimab Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . The restriction will apply for two years. . EMA Report. .

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The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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The Pharma Data

JULY 27, 2021

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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The Pharma Data

DECEMBER 9, 2020

Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” said Michel Vounatsos, Chief Executive Officer at Biogen. Since October 2017 Biogen and Eisai Co.,

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The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application.

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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

OCTOBER 6, 2023

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). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. Read the AgencyIQ analysis here.

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The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

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Agency IQ

FEBRUARY 12, 2024

This is a topic that seems highly related to a recent report from the Reagan-Udall Foundation for the FDA focused on “enhancing post-market evidence generation for medical products” that calls for a “learning health care system.”

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Nick Pittman, Marketing Manager, Global Biopharmaceutical Business, Waters Corporation, on: ‘Robust multi-level LC-MS workflows for biosimilar comparability assessment’.

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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. Priority A List. Priority B List.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 20, 2023) (“The lack of an equivalent IVD on the market is the primary reason labs develop LDTs.”) [7] PRIA. 8] FDA assumes that user fees will cover much of the increased costs.

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