December 12, 2024
Press Release ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that […]
November 14, 2024
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October 13, 2024
U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE– September 4, 2024 Arlington, VA- U.S. physicians overwhelmingly support maintaining the Food and Drug Administration’s (FDA’s) current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic […]
October 5, 2024
Lower med standards endangers health Altoona Mirror Opinion Oct 2, 2024 Dr. Ralph McKibbin As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision. When physicians recommend treatments, we rely on years of training, clinical evidence, and the unique medical history of […]
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
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On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a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 […]
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 21, 2024
ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the […]
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 […]
