Genzyme: Fill/finish causes Thyrogen shortage

Genzyme is advising U.S. doctors to prepare for a mid-April to mid-June shortage of Thyrogen. And the European Medicines Agency says Genzyme Europe BV has warned the thyroid cancer treatment will be in short supply until July.

The EMA says Genzyme will meet approximately 45 percent of EU demand in the interim. Global supply is expected to fluctuate through July, according to the Boston Globe.

The shortage is being attributed to "a manufacturing issue" by the EMA. A Genzyme announcement says the drugmaker "continues to work toward obtaining regulatory approvals worldwide for the fill/finish transfer to a third-party contract manufacturing facility."

Revalidation of fill/finish equipment caused a delay last fall in Thyrogen shipping. At that time, fill/finish was the only part of Thyrogen production taking place at Genzyme's Allston Landing site, now operating under consent decree with the FDA. Genzyme was then in the process of moving the fill/finish operations out of the Boston area site in accordance with the decree.

- see the Genzyme announcement
- get the EMA announcement
- here's the Globe report

Suggested Articles

Hospital-backed Civica Rx has struck a deal for a CDMO to help it develop its own brand of drugs, for which it will own the rights.

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.

WuXi Biologics is taking control of a Bayer plant in Germany and agreed it could serve as a backup facility for supply of hemophilia drug Kovaltry.