By Donald
Zuhn --
In April, Abbott Laboratories filed a
Citizen Petition with the U.S. Food and Drug Administration, asking the agency
to refrain from accepting biosimilar applications under the Biologics Price
Competition and Innovation Act (BPCIA) that cite reference products (biologics)
for which a biologics license application (BLA) was submitted to the FDA prior
to March 23, 2010 (see "Abbott Asks FDA to Refuse Certain Biosimilar
Applications").
The BPCIA, which provides an approval pathway for biosimilar biological
products and constitutes a portion of the Patient Protection and Affordable
Care Act that was signed into law on March 23, 2010, allows the FDA to accept
biosimilar applications four years after a reference product has been licensed
and to approve such applications twelve years after the reference product has
been licensed.
In its Petition, Abbott specifically asked
the FDA to:
[C]onfirm that it will not accept for filing, file, approve, or discuss
with any company, or otherwise take any action indicating that the agency will
consider, any application or any investigational new drug application (IND) for
a biosimilar that cites, as its reference product, BLA 125057 for Humira®
(adalimumab) or any other product for which the biologics license application
(BLA) was submitted to FDA prior to March 23, 2010, the date on which the BPCIA
was signed into law.
Abbott explained that the FDA should
refuse biosimilar applications for all pre-enactment reference products,
including its own biologic Humira®, because to approve such applications would
constitute a taking under the Fifth Amendment of the U.S. Constitution, which
requires just compensation. Noting that
"[a]n innovator's resulting license application typically reflects more
than a decade of research and contains analytical, preclinical, and clinical
data, as well as detailed manufacturing information, most of which qualifies as
trade secrets," Abbott contended that "[t]hese trade secrets are the
private property of the reference product sponsor and are therefore protected
by the Fifth Amendment to the U.S. Constitution." According to
Abbott's Petition, "[w]hen FDA approves a biosimilar biological product on
the grounds that the reference product has been shown safe, pure, and potent,
it uses these trade secrets.
In a letter sent to Abbott's
counsel on October 1, the FDA noted that it had "not yet resolved the issues
raised in [Abbott's] citizen petition."
The letter, which was sent by Jane Axelrad, Associate Director for
Policy for the Center for Drug Evaluation and Research (CDER) at the FDA,
states that the agency "has been unable to reach a decision on [Abbott's]
petition because it raises complex issues requiring extensive review and
analysis by Agency officials." The
FDA's letter was provided in accordance with 21 C.F.R. 10.30(e)(2), which
requires that the agency respond to a citizen petition within 180 days of
receipt by approving the petition, denying the petition, or providing a "tentative
response" indicating why the agency has been unable to reach a decision on
the petition. The FDA's letter closes by
noting that the agency will respond to the petition as soon as it reaches a
decision on Abbott's request.
Additional information regarding the
citizen petition can be found here.
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