November 14, 2024
SAVE THE DATE: ASBM and GaBI to Present Webinar on the Biosimilar Red Tape Elimination Act October 31st On October 31st, ASBM and the Generics and Biosimilar Initiative will present a webinar focusing Senate Bill 2305, the Biosimilar Red Tape Elimination Act. Health policy experts will review current U.S. biosimilar approval and substitution policies, discuss the […]
November 14, 2024
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September 27, 2024
Prioritize Patient Treatment Stability, Physician Confidence Michael ReillySeptember 25, 2024 Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices […]
August 27, 2024
On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. From ASBM’s comments: In addition to the FDA […]
August 27, 2024
August 23, 2024
ASBM Whitepaper: Misinformation About Interchangeable Biosimilars Undermines US Health Policy, Physician Confidence, and Patient Health On July 16th, GaBI Journal published a whitepaper authored by ASBM Chairman Ralph McKibbin, MD and Executive Director Michael Reilly, which underscores the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled “Misinformation about interchangeable […]
July 16, 2024
WASHINGTON, July 16, 2024 – The Alliance for Safe Biologic Medicines (ASBM) announces the publication of a paper underscoring the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled “Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health,” the paper discusses the […]
June 7, 2024
ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM was well represented at the conference, with several member groups were in attendance including the International Cancer Advocacy Network (ICAN), […]
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 […]
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 […]
