ASBM Statement on CMS Announcement of 15 Additional Drugs Subject to Government Price Controls On January 17th, the Centers for Medicare & Medicaid Services (CMS) announced an additional 15 drugs that will be subject to price controls under the Inflation Reduction Act (IRA). This expansion continues a flawed policy that threatens innovation and jeopardizes patient access […]
Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing […]
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 […]
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 […]
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), […]
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 […]
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 […]
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 […]
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 […]
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 […]
