FDA To Genzyme: Another Myozyme BLA, Please
This article was originally published in The Pink Sheet Daily
Agency’s demand for second Pompe’s filing delays 2,000-liter scale-up.
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BioMarin showed that the Vimizim BLA did not have enough data to prove that clinical and commercial sites are different. That’s not the same as concluding there is no difference between the sites, FDA said.
Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.
The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter