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Recall of Anemia Drug Omontys Rings Alarm Over Biosimilars -- ATLANTA, Feb. 27, 2013 /PRNewswire-USNewswire/ --
ATLANTA, Feb. 27, 2013
/PRNewswire-USNewswire/ -- Makers of innovative biologics have
legitimate reason to sound alarms about automatic substitution of
biosimilars that have not proven their interchangeability – and it's not
just because of the potential impact to their bottom line. That point
was driven home by the recent recall of Affymax Inc. and Takeda
Pharmaceutical Co. Ltd.'s anemia drug Omontys (peginesatide), according
to BioWorld.
Though
Omontys is not a biosimilar, the unexpected postmarketing reports of
serious hypersensitivity reactions (three patient deaths) linked to the
erythropoiesis-stimulating agent (ESA) served as a reminder of the
variability of biologics, their sensitivity to minute manufacturing
changes and the difficulty of catching a rare safety signal in the
full-blown biologic development process – let alone an abbreviated
biosimilar path, as noted in a blog post by BioWorld Washington Editor Mari Serebrov......
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