title: Molecular pharming's foot in the FDA's door: Protalix's trailblazing story.
abstract: OBJECTIVE
  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.
authors.affiliation: School of Life Sciences and The Biodesign Institute, Arizona State University, P.O. Box 874501, Tempe, AZ, 85287-4501, USA. tsafrir.mor@asu.edu.
authors.forename: Tsafrir S
authors.initials: TS
authors.lastname: Mor
mesh_terms: D001688:Biological Products; D005962:Glucosylceramidase; D006801:Humans; D058634:Molecular Farming; D010940:Plant Proteins; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D010940:Plant Proteins; D005962:Glucosylceramidase; C582473:taliglucerase alfa
keywords: Ebola; FDA-approval; Gaucher’s disease; Molecular pharming; Plant-derived biologics