WASHINGTON, March 6, 2015 /PRNewswire-USNewswire/ -- The
Alliance for Safe Biologic Medicines today commended the U.S. Food
and Drug Administration (FDA) on its approval of the first
biosimilar to be available for sale in the U.S. market. Approval of
Novartis' Zarxio (filgrastim-sndz), biosimilar to Amgen's Neupogen
(filgrastim), was widely expected following the January
recommendation by an FDA advisory panel that it be approved for all
five indications for which the reference product is approved.
"The approval of the first biosimilar is a milestone for the
agency and a significant positive development as patients and their
physicians will have more treatment options," said ASBM chairman
Harry L Gewanter, MD. "We are particularly encouraged by the
FDA's recognition that a biosimilar is a different medication,
distinct from its reference product, and that the distinguishable
name given to this first biosimilar (filgrastim-sndz) allows
healthcare providers to clearly differentiate it from the innovator
medicine. The FDA is known around the world as a leader in patient
safety, and distinguishable names are an affirmation of its
commitment to transparency and accountability, and will make a
difference in the safety of biologic medicines around the world.
ASBM strongly encourages FDA to continue to use distinguishable
naming for all future biosimilars it approves," Gewanter added.
ASBM joined with more than 70 patient and physician groups in
authoring a letter to FDA in August
2014 encouraging distinguishable naming of biosimilars. The
FDA has stated, however, that the distinguishable naming of
filgrastim-sndz should not interpreted as reflecting the agency's
support for a comprehensive policy of distinguishable naming for
all biologics, including biosimilars. Such guidance on biosimilar
naming is expected to be forthcoming shortly.
While "substantially similar" to the innovator product
filgrastim, filgrastim-sndz has not yet received a designation of
"interchangeable" by the FDA. Such a designation would indicate
that switching between it and its reference product should produce
the same effects in patients while posing no additional risks.
Under the Biologics Price Competition and Innovation Act of 2009
(BPCIA), which lays out the biosimilar approval process, only
biosimilars designated "interchangeable" may be substituted by a
pharmacist without physician involvement.
One area of concern, however, is in the labeling of Zarxio. "The
labeling of Zarxio does not state that it is not interchangeable
with its reference product, what data were supplied to earn
approval is not specified, nor whether or not the product was
studied in all the indications for which it was approved. If we are
to ensure that biosimilars are to be accepted and successful,
patients and physicians need clarity in both labeling and naming."
Gewanter said.
About the Alliance for Safe Biologic
Medicines
The Alliance for Safe Biologic
Medicines (ASBM) is an organization composed of diverse healthcare
groups and individuals from patients to physicians, biotechnology
companies that develop innovative and biosimilar medicines and
others who are working together to ensure patient safety is at the
forefront of the biosimilars policy discussion.
For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
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SOURCE Alliance for Safe Biologic Medicines