FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. report certain device malfunctions, and.

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FDA Law Blog: Biosimilars

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023.

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Big Molecule Watch

AUGUST 25, 2023

With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. Drugs are considered to be “qualifying single-source drugs” if they have been without generic or biosimilar competition for a certain number of years.

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Structure of the eSTAR for De Novos The draft guidance provides a table that offers a high-level overview of the structure of the eSTAR for De Novos, including elements such as the cover letter, device description, proposed indications for use, classification, benefits, risks, mitigation measures, labeling, and supporting data.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Stage 1 is scheduled to take effect on May 6, 2025. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion.

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PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

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pharmaphorum

JANUARY 14, 2021

CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade. Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. Focus on customer engagement impact.

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FDA Law Blog: Biosimilars

JULY 9, 2024

Would any such failure to meet DAP goals be reflected in labeling? This means, under Congress’s direction in FDORA, the FDA should be trying to finalize the Draft Guidance around June 2025. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

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Big Molecule Watch

OCTOBER 31, 2024

This new presentation allows for SELARSDI to expand its label to align with the indications of the reference product STELARA® (ustekinumab). Biosimilars, stated “This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025.”

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Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. Fein, Ph.D., to 1:30 p.m. Or, just click here to order.)

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