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 […]

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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 […]

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 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 way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many […]

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 In early April ASBM Chairman Ralph McKibbin joined with the Pennsylvania Nonmedical Switching Coalition to meet with members of the Pennsylvania House of Representatives Insurance committee to answer questions and advocate regarding the impact of nonmedical switching on patients in the state. PA State Senate bill 348 amends the Unfair Insurance Practices Act to prevent nonmedical switching and a […]

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On April 30, ASBM submitted comments to the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) as part of a public consultation period on the Agency’s “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 […]

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On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, […]

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On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines which focused on unintended consequences for patient access that may result from the implementation of the Inflation Reduction Act (IRA). The webinar focused on the IRA’s price negotiation […]

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