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WASHINGTON — Food and Drug Administration Commissioner Scott Gottlieb on Wednesday accused drug makers who manufacture pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market, costing Americans billions.

The tactics — some of which Gottlieb will refer to as a “toxin” — have prevented other drug makers from launching biosimilar medicines, highly similar versions of the same drugs.

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  • While this statistic seems compelling – “Americans could have saved $4.5 billion in 2017 if all of the FDA-approved biosimilars were actually available in the United States, ” – something is missing. That savings is computed against what figure and what percentage does that saving represent? If total spend is currently is $450 Billion (2016 figure – CNBC), then 40 pct of that is $180 Billion USD. I will never see $4.5 billion USD personally, so I will agree that’s a lot but it represents a discount of ‘only’ 2.5% – scarcely impressive. Driving that spending level down to $175.5 billion USD doesn’t seem like much – “just sayin’ “

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