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.
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.
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.
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:
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1 Humira® (adalimumab) is a registered trademark of AbbVie Inc.
2 Humira® (adalimumab) Prescribing Information
3 US Food and Drug Administration; Biosimilar and Interchangeable Biologics: More Treatment Choices