Will 2016 Be The Year of the Biosimilar?
The first wave of biosimilars seemed ready to come to market in 2015, but only one product actually made it through FDA. The coming year might be the year when multiple biosimilars enter the US.
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As FDA nears the first review deadlines for biosimilar applications, some policy points are coming into sharper focus. Clinical studies for immunogenicity sound like a benchmark requirement, while extrapolation of indications also seems like the agency’s default position.
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The latest flurry of Executive Order activity on drug pricing reinforces the message that the President wants to own the headlines for being tough on the drug industry as Election Day looms. Looking for substance beyond that goal is a fool’s errand – but the headlines could still have significant consequences no matter who wins in November.