FDA Sounds Alarm Over State Biosimilar Drugs Bills

Law360, New York (August 29, 2013, 5:03 PM EDT) -- With California poised to regulate pharmacy substitution of biosimilars, the U.S. Food and Drug Administration on Wednesday used strong language to warn that such state-level efforts threaten to harm public confidence in the lower-priced versions of costly biologics.

While not singling out any measures, the FDA voiced its worries as California was on the verge of joining a handful of other states where lawmakers have enacted various restrictions, such as record-keeping mandates and physician notification requirements, that would apply when pharmacists swap biosimilars for their brand-name...
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