By Ramsey Baghdadi
"The follow-on biologics issue holds the potential for undermining the legitimacy of the whole biotechnology industry," says one senior executive...
Orphaning Biotech? The Impact of Biosimilars on Biotech Investment
An abbreviated follow-on biologics pathway is inevitable, despite the fact that Congress failed to pass legislation in 2007. Will a FOBs pathway adversely impact money flowing into the biotech industry? Unlikely. The impact of the 1983 Orphan Drug Act may be a good model to consider. (This article first appeared in the RPM Report, January 2008).
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In Partnership with Cerba Research
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
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