Biotech Values

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Teva had made manufacturing change or addition to Copaxone manufacture 15 times since original approval based on my count from approval history off FDA database. These changes don't even need label revision. Copaxone isn't regulated as biologic by FDA!

Lumizyme is indicated for late onset Pompe specifically, early onset isn't on label. Myozyme was approved based on early onset infantile study. So technically speaking FDA doesn't need to put switch on label unless Genzyme wants to expand Lumizyme label. Genzyme did have switch from Myozyme to Lumizyme study which was basis of EMA's expansion of Myozyme label as change of manufacture rather than new product.