January 2024 Newsletter

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development On January 25, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”.  The document expresses the EMA’s intent […]

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December 2023 Newsletter

ASBM Records Podcast on Inflation Reduction Act’s Medicare Drug Price Setting  In December, ASBM and its member organization AI Arthritis recorded an episode of the AiArthritis 360 Voices podcast examining how the IRA’s changes to the popular and highly successful Medicare Part D prescription drug benefit will negatively impact patients in coming years. The episode was released December 27th. The […]

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October 2023 Newsletter

ASBM Statement: In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions […]

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November 2023 Newsletter

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted Interchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. The webinar was the fourth in a series covering key health policy issues. The most recent of the webinars, hosted July 29th, examined […]

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September 2023 Newsletter

ASBM Whitepaper to Examine Impact of Medicare Drug Price-Setting on Drug Development, Patient Access The Journal of the Generics and Biosimilars Initiative (GaBI) is currently finalizing a whitepaper based on the July 26th webinar hosted by ASBM and GaBI entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.  View the full webinar here or watch individual […]

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August 2023 Newsletter

ASBM Statement on Announcement of Medicare Drug Price-Setting List   On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year. Over the next 4 years, Medicare will set prices for up to […]

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July 2023 Newsletter

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient AccessOn July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. The webinar focused on the IRA’s price negotiation provisions, which grant new authority to the […]

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June 2023 Newsletter

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences for patient access that may result from […]

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May 2023 Newsletter

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences for patient access […]

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March 2023 Newsletter

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022. The IRA […]

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