Complete Response Letter Received for AVT02 Biologics License Application
14 April 2023 - 2:53AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced that the U.S. Food and Drug Administration (FDA) has
issued a complete response letter (CRL) to its partner Alvotech
(NASDAQ: ALVO) for the Biologics License Application (BLA) for
AVT02, a high-concentration biosimilar candidate for Humira®
(adalimumab). The CRL stated that the application could not be
approved at this time based on deficiencies associated with
Alvotech’s manufacturing facility that must be satisfactorily
resolved. Additional review of the details following the recent
FDA’s re-inspection and CRL are being assessed to determine next
steps.
While this outcome is disappointing, Teva remains fully
committed to its leadership in biosimilars and the partnership with
Alvotech. The Company remains optimistic about additional compounds
in the pipeline and further progress with AVT02.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
innovative medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of innovative medicines and
biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to the development of AVT02, our
proposed biosimilar to Humira® (adalimumab); our ability to
successfully compete in the marketplace, including our ability to
develop and commercialize biopharmaceutical products, competition
for our innovative medicines, including AUSTEDO®, AJOVY® and
COPAXONE®, our ability to achieve expected results from investments
in our product pipeline, our ability to develop and commercialize
additional pharmaceutical products, and the effectiveness of our
patents and other measures to protect our intellectual property
rights; our substantial indebtedness; our business and operations
in general, including, the impact of global economic conditions and
other macroeconomic developments and the governmental and societal
responses thereto, and costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject;
compliance, regulatory and litigation matters, including failure to
comply with complex legal and regulatory environments; other
financial and economic risks; and other factors discussed in our
Annual Report on Form 10-K for the year ended December 31, 2022,
including in the section captioned “Risk Factors.” Forward-looking
statements speak only as of the date on which they are made, and we
assume no obligation to update or revise any forward-looking
statements or other information contained herein, whether as a
result of new information, future events or otherwise. You are
cautioned not to put undue reliance on these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230413005840/en/
IR Contacts United States Ran Meir (267) 468-4475
Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Yiu (973) 265-3752
Yonatan Beker (973) 917-0851
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