In a significant step for generic biologic products, FDA accepted for review the first application for
a biosimilar product. If approved, it could be the first
biosimilar product to enter the U.S. market under the nearly
five-year-old Biologics Price Competition and Innovation Act
("BPCIA"). Last week, Sandoz, a division of Novartis AG,
announced that it had submitted, and FDA had accepted for review,
an application for approval of a biosimilar version of Neupogen, a
filgrastim product made by Amgen Inc. to reduce the risk of
infection in cancer patients who experience a drop in
infection-fighting white blood cells when undergoing certain
treatments.
Before making a decision on the Sandoz application, FDA will likely
establish a naming policy for biosimilar products and determine,
specifically, whether a biosimilar must use the same International
Nonproprietary Name ("INN") as its reference biological
product. Sandoz's product is marketed in other countries and
already has its own INN, but the naming debate has been ongoing for
some time. The World Health Organization recently considered
promoting the use of biological qualifiers for INNs, and earlier
this month, a group of pharmacies, health insurers, and pension
plans urged FDA
not to give unique names to biosimilars, arguing that such a
policy would undermine the potential cost savings generated by
these generic products.
Enacted as part of the Affordable Care Act in 2010, the BPCIA
created an abbreviated regulatory pathway for biosimilars
consisting of a standard, 10-month review process. FDA officials
expect to receive several more biosimilar applications this year,
and the Agency has been preparing for a ramp-up in reviews. In May
2014, FDA issued its fifth draft guidance on biosimilars, which aims to
assist product sponsors with the design and use of clinical
pharmacology studies to support a showing of
"biosimilarity," or that a proposed therapeutic
biological product is similar to its reference product. The
guidance is discussed in further detail in a Jones Day
Commentary.
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