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fhea.com Fitzgerald Health Education Associates, Inc., March 2015
tinuing either the hepatitis C drugs or amiodarone,
or both.
The cause of these adverse events has not been de-
termined. The FDA will conduct further monitoring
and continue to investigate the cause of the
adverse events.
Visit the FDA's
MedWatch page for detailed recom-
mendations.
More Biosimilar Treatment Options On
the Horizon After First Approval
The FDA recently approved
Zarxio (filgrastim-sndz, a
biosimilar to Neupogen, which
is approved to boost white cell
production in patients receiving
chemo therapy), the nation's
first biosimilar medication, and
more biosimilars are expected
to follow.
Biosimilars are a type of bio-
logic medication, defined as be-
ing derived from living organisms that are variable in
nature, generally more complex, and for these reasons
far more complex to manufacture than conventional
medications. Biosimilars are highly similar to an ap-
proved biologic, which is known as the reference
product. Before approving a biosimilar, the FDA must
first verify that there are no clinically meaningful dif-
ferences between the biosimilar and the reference
product and that it will work the same way as the ref-
erence product for approved indications.
The approved biosimilar must also have the same
strength and dosage form and route of administration
as the reference product and be manufactured follow-
ing Current Good Manufacturing Practices.
Biosimilars are likely to create greater competition
in the medical marketplace by increasing treatment
options for patients and leading to less expensive
alternatives to comparable products.
•
News Briefs
C
ontinued from page 20
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