Posted by: Audrey Erbes | April 22, 2008

Biologic Drugs are Not Easy to Replicate

You’ve always heard that biologics are not as easy to replicate as small molecules are. We anticipate “biosimilars” rather than “generics” as a result. Well, now there’s a story to support the difficulty of copying biologics easily…Genzyme has approval for their product Myozyme (a recombinant human acid alpha-glucosidase enzyme (rhGAA)  produced at a 2,000 liter bioreactor scale in the EU and Japan but the FDA requires a new BLA for U.S. approval. 
 
The FDA sees the product produced in the much larger reactor vs that at the 160 liter scale as two different products. The FDA’s decision is based on differences in the carbohydrate structure of the molecules produced in the two bioreactors, according to Genzyme.
Myozyme was approved by the FDA to treat Pompe’s disease in May 2006.
Audrey
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