Abstract
Objectives
This short commentary examines the factors that led to Food and Drug Administration’s approval of the first plant-derived biologic.
Results
In 2012, the first plant-derived protein pharmaceutical (biologic) was approved for commercial use in humans. The product, a recombinant form of human β-glucocerebrosidase marketed as ELELYSO, was developed by Protalix Biotherapeutics (Carmiel, Israel). The foresight to select this particular therapeutic product for development, flawless production pipeline, and serendipity seem to provide the key in explaining how ELELYSO became the first plant-derived biologic to achieve approval by Food and Drug Administration.
Conclusions
While the circumstances that enabled Protalix and its scientists to become the first to arrive at this historic milestone are perhaps unique, it is anticipated that more biologics will follow suit in winning regulatory endorsement.
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Notes
A plant-made poultry vaccine against Newcastle disease virus (created by Dow Agroscience), was approved for use by the US Department of Agriculture in 2006. The vaccine was never commercially produced or used (Vermij 2006).
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Acknowledgments
TSM’s research was funded in part by work was supported in part by the National Institute for Drug Abuse Program Grant P1 DA031340 awarded to the Mayo Clinic and subcontracted to ASU and in part by the National Institute for General Medical Sciences U54 GM094599.
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Mor, T.S. Molecular pharming’s foot in the FDA’s door: Protalix’s trailblazing story. Biotechnol Lett 37, 2147–2150 (2015). https://doi.org/10.1007/s10529-015-1908-z
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DOI: https://doi.org/10.1007/s10529-015-1908-z