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.
White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.