ALVOTECH
6.7.2021 13:24:13 CEST | Business Wire | Press release
Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotech‘s proposed biosimilar to the reference product Stelara®. The objective of the study is to demonstrate therapeutic equivalence between AVT04 and Stelara® in terms of safety, efficacy and immunogenicity in patients with moderate-to-severe chronic plaque psoriasis.
The AVT04-GL-301 study is being conducted in five countries in Central and Eastern Europe and it is expected that approximately 530 patients will be enrolled in the study.
In parallel, Alvotech is also conducting a PK similarity study (AVT04-GL-101) to demonstrate equivalent PK endpoints between the proposed biosimilar and the reference product Stelara. The AVT04-GL-101 study, that is also assessing safety and tolerability, is currently ongoing in Australia and New Zealand and is expected to enroll 294 healthy adult volunteers.
Ustekinumab, which is among the highest selling pharmaceutical products in the world, had worldwide sales of $7.7 bn in 2020.
AVT04 is the second proposed biosimilar product from Alvotech entering clinical studies, the first being AVT02, a proposed biosimilar to Humira®. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira® and is executing a switching study to support its approval as an interchangeable product.
Róbert Wessman, founder and Chairman of Alvotech, commented:
”As a founder, I am extremely proud to see us enter the second proposed biosimilar product into clinical trials. This brings us closer to our mission to expand patient access to high quality biosimilars at an affordable price.”
Mark Levick, CEO of Alvotech, added:
“We are pleased to have reached this important milestone where the first subjects are being enrolled in clinical trials for AVT04, and we look forward to continuing with recruitment and patient follow-up.
Additionally, the initiation of this clinical program, with two studies running in parallel, reinforces our commitment to improving the efficiency of the clinical development, with the ultimate goal of improving the lives of patients suffering from serious chronic or life-threatening diseases, through faster access to high-quality biosimilars.”
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 AVT04 and AVT02:
AVT04 is a monoclonal antibody (mAb) and a proposed biosimilar to STELARA® (ustekinumab). AVT04 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 is a monoclonal antibody (mAb) 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 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”, “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/20210706005375/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Cyviz: Microsoft’s Immersive Approach to Collaboration12.6.2026 09:00:00 CEST | Press release
At Microsoft’s Innovation Hub in Amsterdam, immersive technology is used to enable co-creation rather than one-way presentations. In the company’s Immersive Suite, customers, data experts, and technology specialists come together in a shared environment to address complex challenges more effectively. Watch Video Case Study >> This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612831180/en/ Watch Video Case Study >> https://www.cyviz.com/case-studies/microsoft-immersive-suite/ As business and technology environments grow more complex, establishing shared understanding across disciplines has become critical. The Immersive Suite is designed for active collaboration, where visual narratives, data, and technical content are explored interactively. This allows participants to test scenarios, align perspectives, and move more efficiently from discussion to decision. “We deliberately work with familiar tools like PowerPoint. That all
LTM Launches AI 1000 to Develop the Next Generation of Forward Deployed Engineers12.6.2026 08:14:00 CEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today announced AI 1000, a strategic workforce transformation initiative anchored by a dedicated Center of Excellence (CoE). The program will develop a pool of 1,000+ AI-certified engineers, including Forward Deployed Engineers (FDEs), to help enterprises adopt, deploy, and scale AI. The launch comes amid a major shift in enterprise tech talent. The FDE — among the fastest-growing roles in the AI ecosystem — combines the technical knowledge of LLMs and domain SLMs with business understanding to turn ideas into quantifiable ROI accretive outcomes and to drive client adoption. AI 1000 is LTM’s structured response to this shift: it provides the training, platforms, and governed career frameworks to develop FDEs at scale. AI 1000 takes an end-to-end approach to talent development via a four-stage model: Identify, Enable, Deploy, and Govern. It starts by identifying high-potential engineers using a proprietary AI Readi
NTT DATA Group Appoints Kazuhiko Nakayama as New President and Chief Executive Officer12.6.2026 08:00:00 CEST | Press release
Kazuhiko Nakayama appointed President and CEO of NTT DATA Group; Yutaka Sasaki to become Senior Executive Vice President of NTT, Inc. NTT DATA Group, a global leader in AI, digital business and technology services, today announces that the Board of Directors has approved the appointment of Kazuhiko Nakayama as NTT DATA Group’s new President and Chief Executive Officer, effective June 12, 2026. Yutaka Sasaki, former President and CEO of NTT DATA Group, will assume the role of Senior Executive Vice President of NTT, Inc., effective June 18. Serving most recently as CFO of NTT DATA Group, Nakayama brings proven leadership and a depth of expertise and experience in defining business strategy and delivering growth. He will continue to strengthen the competitive advantages of the $30+ billion business whilst accelerating it’s AI-centered growth strategy across the 70+ countries and regions in which it operates. NTT DATA Group’s growth strategy will focus on two key areas alongside its core b
Venture Global Announces Closing of $2.25 Billion of Senior Secured Notes11.6.2026 23:00:00 CEST | Press release
Venture Global LNG, Inc. (“Venture Global”) announced today that its wholly-owned subsidiary, Venture Global LNG, Inc. (the “Issuer”) has closed its offering of $1.125 billion aggregate principal amount of its 6.375% senior secured notes due 2034 (the “2034 Notes”) and $1.125 billion aggregate principal amount of its 6.625% senior secured notes due 2036 (the “2036 Notes” and, together with the 2034 Notes, the “Notes”). The Issuer used the gross proceeds from the offering to redeem all of the Issuer’s outstanding 8.125% senior secured notes due 2028 (the “Existing 2028 Notes”) and used cash on hand to pay the redemption premium and related fees and expenses for the offering and the redemption. The 2034 Notes will mature on December 15, 2034, and the 2036 Notes will mature on June 15, 2036. The Notes were issued at par. The Notes will initially not be guaranteed by any of the Issuer’s subsidiaries. In the future, certain of the Issuer’s subsidiaries that incur or guarantee certain amount
Venture Global and Atlantic-SEE Announce Expansion of Long-Term LNG Sales and Purchase Agreement with Greece11.6.2026 22:30:00 CEST | Press release
Deal doubles quantity of US LNG to be supplied by Venture Global, expanding existing partnership to bolster Central and Eastern European energy securityBuilds on Venture Global’s regasification capacity investment in the Alexandroupolis LNG import terminal to supply U.S. LNG to the region Today, Venture Global, Inc. (NYSE: VG) and ATLANTIC – SEE LNG TRADE S.A. of Greece announced an expansion of their existing Sales and Purchase Agreement (SPA) for the purchase of U.S. liquefied natural gas (LNG) from Venture Global for twenty years starting in 2030. Under the deal, Atlantic-SEE is doubling their existing contract with Venture Global from a minimum of 0.5 million tonnes per annum (MTPA) to 1.0 million tonnes per annum (MTPA). Atlantic-SEE LNG is a newly formed joint venture announced in November at the 6th Partnership for Transatlantic Energy Cooperation (PTEC) conference hosted in Athens, Greece between Greek companies AKTOR Group and DEPA Commercial. The announcement of this expanded
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom