Transcription of PRESENTED BY: Committee on Rheumatologic Care
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PRESENTED BY: Committee on Rheumatologic Care
american college OF rheumatology . position STATEMENT. subject : Biosimilars PRESENTED BY: Committee on Rheumatologic Care FOR DISTRIBUTION TO: Members of the american college of rheumatology Medical Societies Members of Congress Health Care Organizations/Third Party Carriers Managed Care Entities position : The ACR strongly believes that safe and effective treatments should be available to patients at the lowest possible cost. Decisions regarding the approval and use of biosimilars must be driven by sound science and take into account several observations and guiding principles, including: 1. The size, complexity, and heterogeneity of biologics (and thus biosimilars) necessitate a greater degree of scrutiny in their analytical evaluation than what is required for small molecule generics. 2. In addition to adequate pharmacokinetic and pharmacodynamics studies, clinical data are necessary to ensure the safety and efficacy of biosimilars, and to provide the necessary level of confidence for their use by patients and providers.
AMERICAN COLLEGE OF RHEUMATOLOGY POSITION STATEMENT SUBJECT: Biosimilars PRESENTED BY: Committee on Rheumatologic Care FOR DISTRIBUTION TO: Members of the American College of Rheumatology Medical Societies
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