STAT

SEPTEMBER 23, 2022

Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. the first biosimilar was launched in September 2015. In the U.S.,

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Biosimilars Diabetes Drug Pricing 246

STAT

AUGUST 30, 2023

government’s initial approach to negotiating drug prices could discourage cheaper biosimilar versions of more complex pharmaceuticals that eat up a high portion of total Medicare spending , Bloomberg Law explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.

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Biosimilars Drug Pricing 257

Big Molecule Watch

NOVEMBER 6, 2023

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA.

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Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

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Biosimilars Labelling Drug Pricing 57

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. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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Labelling Drug Pricing Compounding Payment Processing 104

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. This event is part of The Drug Channels 2024 Video Webinar Series.

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