March 2024 Newsletter

May 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. In response, ASBM Executive Director Michael Reilly published a blog post sharing his concerns with the Administration’s proposal to permit widespread automatic (pharmacy-level) substitution of all biosimilars in place of their reference products; without physician approval […]

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February 2024 Newsletter

April 12, 2024

ASBM Joins ICAN, other Patient Advocacy Organizations to Oppose Government Use of “March In Rights” In February, ASBM joined 33 other patient advocacy organizations led by the International Cancer Advocacy Network (ICAN) in a letter to U.S. Congressional leadership, urging them to oppose the use of “march-in rights” to break pharmaceutical patents for drugs developed with […]

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Biden Budget Would Allow Automatic Pharmacy Substitution of ALL Biosimilars, Misunderstands US and EU Substitution Policy

April 11, 2024

by Michael Reilly, ASBM Executive Director The Biden Administration’s FY25 Budget, unveiled on March 11, 2024, takes aim at prescription drug costs but misses the mark and hurts rather than helps patients. Again. (Read my concerns with the Administration’s Medicare Part D price-setting system here). This latest proposal would loosen the review criteria for some […]

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ASBM Releases Fact Sheet on Emerging Challenges to Interchangeable Biosimilars Policy

February 5, 2024

On January 31st, ASBM released a fact sheet describing a variety of proposed policy changes at the state and federal level which would weaken the interchangeable biosimilar standard, or circumvent the patient protections it provides. These include new bills and regulations at the federal level, as well as state legislation and proposals which threaten to […]

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EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development

February 1, 2024

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 to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data; it also […]

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GaBI Journal Publishes ASBM Whitepaper on Medicare Part D Price Setting 

February 1, 2024

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines”. The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023. It examines the likely negative effects of IRA’s price negotiation provisions, which allow the […]

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January 2024 Newsletter

February 1, 2024

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

January 12, 2024

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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ASBM Submits Comments Opposing CMS Proposal to Permit Medicare Part D Plans to Substitute Non-Interchangeable Biosimilars

January 6, 2024

In November, 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 such as rheumatoid arthritis, Crohn’s disease and cancer. Read ASBM’s statement on the announcement here.  CMS accepted public comments on […]

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ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars 

December 20, 2023

On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly […]

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