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Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Proposing to change this standard in the U.S.
Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA.
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