Alvotech Announces Positive Top-Line Results for Switching Study Between Proposed Biosimilar AVT02 and Humira®

Rhea-AI Summary

Alvotech announced positive top-line results from a randomized study evaluating the bioequivalence of its biosimilar AVT02 (adalimumab) and Humira, demonstrating no significant differences in efficacy, safety, or immunogenicity. This study, aimed at supporting FDA approval as an interchangeable product, involved 568 patients across Europe. Alvotech is the first to submit a high-concentration biosimilar for Humira and has partnered with Teva Pharmaceuticals for U.S. commercialization. These results mark a significant milestone towards providing affordable treatment options for chronic conditions.

Positive

• Successful results from the AVT02 biosimilar study indicate bioequivalence to Humira.
• No significant differences in clinical efficacy, safety, or immunogenicity between AVT02 and Humira.
• Alvotech is the first to conduct a switching study for a high-concentration biosimilar to Humira.
• Partnership with Teva Pharmaceuticals enhances commercial prospects in the U.S.

Negative

• None.

REYKJAVIK, Iceland--(BUSINESS WIRE)-- Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced top-line results from a randomized study in patients that demonstrate bioequivalence of repeated switches between administration of Humira® (adalimumab) and Alvotech’s high-concentration biosimilar candidate, AVT02 (100 mg/mL) to administration of Humira without switching. Further, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort.

The purpose of the switching study is to support the potential approval of AVT02 by the U.S. Food and Drug Administration as an interchangeable product with Humira¹. Alvotech is the only known company that has both developed and submitted a filing for a high-concentration biosimilar candidate to Humira, as well as conducted a switching study to support potential approval as an interchangeable product. Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT02 in the United States.

Adalimumab inhibits Tumor Necrosis Factor², which is a protein in the body that causes inflammation. Adalimumab is used to treat certain inflammatory conditions. Humira recorded sales of about US$20 billion in 2018, making it the largest-selling biologic in the world. Today, over 80 percent of the usage of Humira in the United States is the high-concentration strengths.

“Alvotech is showing true momentum in its goal of developing high-quality biosimilars, and these study results are another positive milestone,” said Róbert Wessman, Founder and Chairman of Alvotech. “Patients are waiting, and we’re more committed than ever to help those living with serious chronic diseases.”

“Completing this key milestone for Alvotech is an extremely rewarding and a positive step toward providing patients an affordable and accessible alternative to the high-concentration version of Humira,” said Mark Levick, CEO of Alvotech.

The clinical trial (AVT02-GL-302; NCT04453137) included 568 patients across approximately 30 centers in Europe. After completing the lead-in period of 12 weeks under treatment with the reference product, eligible patients were randomized into either of the two arms of the switching module: the first group continued treatment with Humira, the second group continued treatment receiving alternating doses of AVT02 and Humira for an additional 16 weeks.

According to the FDA, an interchangeable product may be substituted for the reference product without the intervention of a prescriber³. The substitution may occur at the pharmacy, much like how generic drugs are substituted for brand name drugs, subject to varying U.S. state pharmacy laws. Biosimilar and interchangeable products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. The concept of interchangeability for biosimilars was signed into law through the Biologics Price Competition and Innovation Act (BPCIA) in 2010. In order to be considered interchangeable, a biosimilar must meet additional requirements, including the execution of a “switching study,” utilizing the reference product and biosimilar product in patients. The vast majority of states have passed laws regarding substitution for interchangeable products.

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. Robert 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.

About AVT02-GL-302:
AVT02-GL0302 is a multicenter, randomized, double-blind, parallel-group study to evaluate PK, efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and AVT02, followed by an optional safety Extension Phase. The study is composed of 3 phases: (1.) a lead-in phase, where all patients receive Humira; (2.) a switching phase, where one cohort receive Humira and one cohort switches between AVT02 and Humira; and (3.) an optional open-label extension phase, where all patients receive AVT02. The study enrolled 568 participants.

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 these slides and/or the press release of them should be construed as a profit forecast or profit estimate. Wherever possible, words such as “anticipate,” “believe,” “expect,” “may,” “could,” “will,” “potentia,” “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.

¹ Humira® (adalimumab) is a registered trademark of AbbVie Inc.
² Humira® (adalimumab) Prescribing Information
humira (rxabbvie.com)
³ US Food and Drug Administration; Biosimilar and Interchangeable Biologics: More Treatment Choices
https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices

View source version on businesswire.com: https://www.businesswire.com/news/home/20210909005945/en/

Alvotech

Elisabet Hjaltadottir

Corporate Communications

Email: Alvotech.media@alvotech.com

Source: Alvotech

FAQ

What are the results of Alvotech's AVT02 study compared to Humira?

The study showed bioequivalence of AVT02 and Humira, with no significant differences in efficacy, safety, or immunogenicity.

What is AVT02 and its significance in the market?

AVT02 is a proposed biosimilar to Humira, aimed at providing an affordable alternative for treating chronic inflammatory conditions.

What is the role of Teva in Alvotech's AVT02 commercialization?

Teva Pharmaceuticals is the exclusive strategic partner for the commercialization of AVT02 in the United States.

What does the study involving AVT02 entail?

The study involved 568 patients and assessed the effects of switching between AVT02 and Humira over a 16-week period after an initial 12-week treatment with Humira.

What is the FDA's stance on interchangeable biosimilars?

The FDA allows interchangeable biosimilars to be substituted for reference products without prescriber intervention, similar to generic drugs.