EMA Orphan Approval Path Seems More Twisty After Pfizer/Protalix’s Elelyso Stumbles
This article was originally published in The Pink Sheet Daily
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.
Pfizer's licensing deal with Protalix for global rights to the enzyme replacement therapy taliglucerase for the treatment of Gaucher disease, announced Dec. 1, signals the drug giant's interest in the orphan drug space. It also plays into the company's biosimilar strategy, given that taliglucerase will likely be positioned as a lower-cost alternative to Genzyme's Cerezyme (imiglucerase)