Complete Response Letter Received for AVT02 Biologics License Application

Rhea-AI Summary

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has received a complete response letter (CRL) from the U.S. FDA regarding its partner Alvotech's (NASDAQ: ALVO) Biologics License Application for AVT02, a biosimilar to Humira (adalimumab). The FDA's CRL indicates that the application cannot be approved due to deficiencies identified at Alvotech's manufacturing facility, which need resolution. Despite this setback, Teva reaffirms its commitment to leadership in the biosimilars market and expresses optimism about its product pipeline, including further advancements with AVT02.

Positive

• Teva remains committed to leadership in biosimilars.
• The company shows optimism about additional compounds in its pipeline.

Negative

• FDA issued a complete response letter for AVT02, delaying approval.
• Deficiencies identified at Alvotech's manufacturing facility could impact timelines.

TEL AVIV, Israel & PARSIPPANY, N.J.--(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.

View source 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

Source: Teva Pharmaceutical Industries Limited

FAQ

What was the outcome of Teva's partnership with Alvotech regarding AVT02?

Teva received a complete response letter from the FDA for Alvotech's AVT02 application, delaying approval.

What are the implications of the FDA's complete response letter for TEVA stock?

The CRL signifies regulatory setbacks that may affect investor confidence and TEVA's stock performance.

Is Teva still optimistic about its biosimilar pipeline after the CRL?

Yes, Teva remains optimistic about its biosimilars pipeline and other compounds despite the CRL.

What deficiencies were noted in the FDA's complete response letter regarding AVT02?

The FDA noted deficiencies at Alvotech's manufacturing facility that must be resolved before approval.

How does the CRL affect Alvotech (ALVO)?

The CRL impacts Alvotech's ability to bring AVT02 to market, potentially affecting its stock.