ARTICLE | Regulation

A liter dissimilar

April 28, 2008 7:00 AM UTC

A decision by FDA to require separate BLAs for batches of Myozyme alglucosidase alfa manufactured in two different facilities is certain to play into debates about legislation and regulation of biosimilars.

In April 2006, the agency approved a BLA for Myozyme for Pompe's disease as manufactured in a 160-liter bioreactor. The EMEA also approved Myozyme in April 2006, but only when produced in the company's 2,000-liter commercial-scale bioreactor. ...