Molecular pharming’s foot in the FDA’s door

Protalix’s trailblazing story

Research output: Contribution to journalArticle

17 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)2147-2150
Number of pages4
JournalBiotechnology Letters
Volume37
Issue number11
DOIs
StatePublished - Nov 29 2015

Fingerprint

Glucosylceramidase
United States Food and Drug Administration
Biological Products
Drug products
Foot
Pipelines
Proteins
Drug Approval
Plant Proteins
Israel
Pharmaceutical Preparations
Therapeutics

Keywords

  • Ebola
  • FDA-approval
  • Gaucher’s disease
  • Molecular pharming
  • Plant-derived biologics

ASJC Scopus subject areas

  • Biotechnology

Cite this

Molecular pharming’s foot in the FDA’s door : Protalix’s trailblazing story. / Leket-Mor, Tsafrir.

In: Biotechnology Letters, Vol. 37, No. 11, 29.11.2015, p. 2147-2150.

Research output: Contribution to journalArticle

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