Genzyme manufacturing issue causes Thyrogen shortage
Genzyme will be unable to meet demand for Thyrogen until July 2011 because of a manufacturing issue.
Supplies of the product, used in thyroid cancer, will meet 45 per cent of demand in the European Union (EU) over the next few months. The European Medicines Agency (EMA) has been informed of the shortage and interim recommendations have been made.
Genzyme also expects shortages in the US from mid-April through to mid-July. Regional disparities in supply are expected to continue because of logistical challenges related to the limited inventory.
To overcome shortages Genzyme is working to obtain regulatory approval for the transfer of fill/finish to a contract manufacturing facility.