EMA Orphan Approval Path Seems More Twisty After Pfizer/Protalix’s Elelyso Stumbles
This article was originally published in The Pink Sheet Daily
Executive Summary
The European Medicines Agency will not recommend Pfizer/Protalix’s Elelyso for type 1 Gaucher, maintaining that it is too similar to Shire’s Vpriv, despite the firms’ argument that their product offers better bone marrow data and alleviates shortage concerns.
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Gaucher disease enzyme-replacement therapy Elelyso is the first FDA-approved plant-cell based recombinant therapeutic protein, a biosimilar option that may eliminate the production-related problems Genzyme’s Cerezyme and Shire’s Vpriv face with animal cell-based processes. Pfizer is launching Elelyso at a 25% discount to Cerezyme and promising to maintain a two-year supply.
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