Co-authored by Patricia Granahan and Kenneth J. Dow
PROLOGUE: The world of pharmaceuticals and patent law can be exceedingly complex. Or, to twist Gertrude Stein's words, it is not correct that a drug is a drug is a drug. Nowhere is this more true than with "follow-on protein products," the term the U.S. Food and Drug Administration (FDA) adopted in 2004 for proteins intended as similar versions of already approved protein pharmaceutical products.
In a bit more detail (as explained by PrimeZone), follow-on protein products "are 'copies' of recombinant DNA-derived protein products made by companies other than the innovator [company] and using an abbreviated approval path. These products are generally more difficult to make than small-molecule generic drugs due to their greater complexity." Follow-on protein products are also sometimes referred to as generic biologics.
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Originally published by Health Affairs
The authors thank Audrey Phillips, Alan Bennett, Joanna Wu, and Greg Glover for their comments on this paper.
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