FDA Law Blog: Biosimilars

JANUARY 22, 2024

Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. Clinical Trials. We’ve recently discussed FDA’s clinical trial oversight , and OC didn’t miss the chance to emphasize that it has a role in developing policy about how FDA-regulated research should be conducted.

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The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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The Pharma Data

JULY 29, 2021

100% Efficacy Observed in Phase 2b Trial of RSV Adult Vaccine Candidate; Provides New Data Updates on its COVID-19 Vaccine Booster and Oral COVID-19 Antiviral Programs As Part of a Broader Review of 8 Potentially First-in-Class Compounds NEW YORK, NY, Wednesday, July 28, 2021 – Pfizer Inc. Second-Quarter 2021 Revenues of $19.0 Total Oper.

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The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

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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. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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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.

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The Pharma Data

SEPTEMBER 17, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

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Agency IQ

JUNE 29, 2023

June 2023 Sunlamp Products; Amendment to the Performance Standard (Final Rule) FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

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Agency IQ

JUNE 2, 2023

By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources. not discontinued) and are available for sale.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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FDA Law Blog: Biosimilars

OCTOBER 18, 2023

The Draft Guidance also describes the types of data that may constitute clinical data supporting a 510(k), drawing on previous recommendations of the International Medical Device Regulators Forum (see “ Clinical Evidence – Key Definitions and Concepts ”). electronic health records, claims).

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. Net Revenues of $4.305 Billion and International Profit Sharing of $1.009 Billion; Global Venclexta Net Revenues Were $1.337 Billion. Percent on a Reported Basis, or 13.4

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Agency IQ

MAY 3, 2024

AgencyIQ also in attendance.

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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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The Pharma Data

MAY 15, 2023

He held other supply chain roles of increasing responsibility over his 35 years successful international career with Procter & Gamble and served under three different CEOs. Remco also serves on the Board of Directors at Swiss International Air Lines since 2021.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

It is now unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense an anabolic steroid or product containing an anabolic steroid, unless the product bears a label clearly identifying it as such by International Union of Pure and Applied Chemistry (“IUPAC”) nomenclature.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs.

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FDA Law Blog: Biosimilars

JULY 4, 2023

A hearing for a final order is not a formal, trial-type, evidentiary hearing. Ordinarily, the decision will be issued within 30 days from receipt of the request. In making its determination, FDA may consider only information and data that are based on “relevant and reliable scientific principles and methodologies”.

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The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. percent, a decrease of 0.3

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Agency IQ

JUNE 29, 2023

e.g., “ In a clinical trial, Drug X reduced the risk of stroke by 50%. By way of example , if a company claims that a trial showed that 68% of patients treated with Drug X experienced a reduction in blood glucose levels, they should also note the reduction experienced by patients treated with the standard of care or placebo.

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The Pharma Data

AUGUST 13, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

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The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Aubagio ® sales decreased 1.1% In the U.S.,

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The Pharma Data

AUGUST 13, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. net revenues of $999 million and international profit sharing of $269 million. The positive CHMP opinion is based on data from the VIALE-A and M14-358 trials and represents the third positive CHMP opinion for an extension of indications for Venclyxto. AbbVie Inc.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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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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Agency IQ

JUNE 9, 2023

The low prevalence of individual orphan diseases poses challenges for building a scientific knowledge base and poses hurdles for clinical trial conduct, though collectively the diseases have a big impact. population) is considered heterogenous due to the developing physiological characteristics which makes clinical trial conduct challenging.

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Drug Channels

SEPTEMBER 28, 2021

on international benchmarking goes viral Amazon is finally disrupting CVS—but not how you expected Plus, the best article ever about Elizabeth Holmes’s Theranos trial. P.S. Please join the more than 12,500 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

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The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., Chief Executive Officer of Alexion. ” Third Quarter 2020 Financial Highlights.

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Agency IQ

SEPTEMBER 1, 2023

MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway Today, the U.K.’s The Access Consortium is a work-sharing initiative involving Australia, Canada, Singapore and Switzerland, to enhance international cooperation and increase regulator capacity.

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The Pharma Data

OCTOBER 29, 2020

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions. “We But it was a true Eureka moment when we realized that combining Australia’s 43.5%

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The Pharma Data

MAY 3, 2021

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. Report. . © 2021 Regulatory Affairs Professionals Society.

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