FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. Final Guidance at 2. 1395w-114c(b)(4)(B)(i).

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Drug Channels

JUNE 25, 2024

Attendance will be limited, so click here to request an invite for our March 2025 event. Happy 248th birthday, America! Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. What ever happened to that thing?

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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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Drug Channels

JANUARY 22, 2025

For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. In fact, nearly all marketed Humira biosimilars are excluded from the larger PBMs 2025 formularies.

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Drug Channels

APRIL 1, 2025

Click here to see the original post from January 2025. For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. What do you think? All rights reserved.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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