The Florida Society of Rheumatology (FSR) has joined other rheumatology associations in expressing significant concerns regarding the Biosimilar Red Tape Elimination Act. In a letter addressed to congressional leaders, FSR emphasized that this legislation could profoundly affect patients and their healthcare providers throughout Florida and beyond.
Currently, the Food and Drug Administration's (FDA) strict review process for determining the interchangeability of biosimilars requires comprehensive clinical switching studies to demonstrate that there are no clinically meaningful differences in safety, efficacy, and quality compared to reference biologic products. The FSR argues that eliminating these mandatory studies would undermine the confidence of prescribers, including rheumatologists, in the safety of biosimilars.
Additionally, the letter highlights concerns over potential changes in health insurance plans and Pharmacy Benefit Managers (PBMs), which may lead to non-medical switching of patients between biosimilars based on formulary preferences rather than clinical appropriateness.
While acknowledging the potential for biosimilars to provide more affordable treatment options and improve adherence for rheumatic disease management, the FSR urges lawmakers to maintain current FDA standards to ensure patient safety and provider trust.
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