Cong. Eshoo Issues Letter to FDA Requesting Status of Biosimilar Policies

In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability.

To read letter, click here.

Latest News

March 2024 Newsletter

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 […]

February 2024 Newsletter

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 […]

ASBM Releases Fact Sheet on Emerging Challenges to Interchangeable Biosimilars Policy

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 […]