Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira® (adalimumab)

Rhea-AI Summary

Alvotech announced the FDA has deferred action on the application for AVT02, a proposed biosimilar to Humira, pending necessary facility assessments. The FDA can defer without identifying deficiencies when inspections cannot be completed due to factors such as travel restrictions. Alvotech collaborates with the FDA for safe coordination of inspections. They are the only company that has conducted a switching study supporting interchangeability for Humira's high-concentration biosimilar. Teva Pharmaceuticals is the exclusive partner for AVT02's commercialization in the U.S.

Positive

• Alvotech has conducted a successful switching study for AVT02, supporting potential interchangeability.
• Teva Pharmaceuticals is the exclusive partner for U.S. commercialization of AVT02.

Negative

• FDA deferral of action on AVT02 application could delay market entry.

REYKJAVIK, Iceland--(BUSINESS WIRE)-- Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced that the FDA is deferring action on the application for AVT02, the company’s proposed biosimilar to Humira®, until facility assessments can be completed. The FDA can defer action¹ when no deficiencies have been identified and the application otherwise satisfies the requirements for approval, but an inspection(s) is necessary yet cannot be completed due to factors including travel restrictions. Alvotech continues to work with the FDA to coordinate the required inspection(s) in a safe and adequate manner.

Alvotech is the only known company that has both submitted a Biologics License Application (BLA) for a high-concentration biosimilar candidate to Humira, the most commonly utilized strength of the product on the market, and has successfully conducted a switching study in support of an FDA designation of interchangeability and correspondingly the potential for product substitution at the pharmacy level. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT02 in the United States.

In addition to the positive top-line results seen in the switching study, Alvotech on Sept. 16, 2021 received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of AVT02 in the EU. The European Commission (EC) will consider the CHMP's positive opinion when deciding to grant a marketing authorization for AVT02 at its October meeting.

The Biden Administration and the U.S. Department of Health and Human Services (HHS) have expressed support for the increased competition and healthcare savings generated by biosimilars and interchangeable biosimilars.

“The U.S. Government has made it clear that increasing the affordability of prescription drugs, through enhanced competition in biologic medicines, is a significant priority,” said Mark Levick, CEO of Alvotech. Adding, “We strongly share the view that biosimilar medicines and interchangeable biosimilars present a unique opportunity to contribute to improving equity in healthcare”

1. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/manufacturing-supply-chain-and-drug-inspections-covid-19

About Alvotech:

Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotech’s shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Róbert Wessman, Fuji Pharma from Japan, YAS Holdings form Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, ATHOS (Strüngmann Family Office) from Germany and CVC Capital Partners and Temasek from Singapore through their participation in Alvogen.

Alvotech’s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.

About AVT02:

AVT02 is a monoclonal antibody and a proposed biosimilar to Humira (adalimumab). AVT02 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.

Forward Looking Statement:

Except for historical information contained herein, the matters set forth in this press release are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are not based on historical facts but rather on our expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this press release about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward looking statements. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements. Any of the assumptions underlying forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. 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/20210920005626/en/

Alvotech

Elisabet Hjaltadottir

Corporate Communications

Email: Alvotech.media@alvotech.com

Source: Alvotech

FAQ

What is AVT02 related to Teva Pharmaceuticals?

AVT02 is a proposed biosimilar to Humira developed by Alvotech, with Teva Pharmaceuticals as the exclusive commercialization partner in the U.S.

Why did the FDA defer action on AVT02?

The FDA deferred action on AVT02 until facility assessments can be completed, although no deficiencies were identified.

What are the implications of the FDA's deferral for Teva's stock?

The FDA's deferral on AVT02 may delay potential revenue from its commercialization, impacting Teva's stock performance.

What are the recent developments regarding AVT02?

Alvotech received a positive opinion from the EMA for AVT02, and is awaiting the European Commission's decision in October.

How does AVT02's status affect the biosimilars market?

The FDA's deferral could influence the timeline for AVT02's entry into the biosimilars market, affecting competition and pricing.