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
Vedanta Ltd Doubles Zinc Capacity in South Africa with US$ 600 Mn investment19.10.2026 19:19:00 CEST | Press release
Vedanta Limited doubled its annual zinc production capacity to 500,000 tonnes1in South Africa through an investment of nearly US$ 600 Mn at Gamsberg (Phase II) at Vedanta Zinc International (VZI). Gamsberg has one of the world’s most significant zinc deposits and is VZI’s flagship zinc mine. Inaugurated by South African President Cyril Ramaphosa and Vedanta Limited Director Priya Agarwal-Hebbar, this expansion marks one of the decade’s largest mining investments in South Africa. It advances Vedanta Limited’s position as the world’s largest2 zinc producer, with a vision of achieving 3 million tonnes of annual production across India and South Africa. Of this, 2 million tonnes are targeted from its subsidiary, Hindustan Zinc Limited the world’s largest integrated zinc producer, while Vedanta Zinc International business aims to contribute 1 million tonnes annually. This expansion strengthens the ZAR 21 Bn (nearly US$ 1.5 Bn) investment commitment Vedanta made at the 2018 South Africa Inve
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 18:00:00 CEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
Roquette Brings Broad Portfolio of Excipient Solutions and Technical Expertise to AAPS PharmSci 360 202619.10.2026 16:00:00 CEST | Press release
Roquette, a global leader in plant-based ingredients, excipients and pharmaceutical solutions, will showcase its expansive portfolio of excipients, capsules, coatings, and biopharma solutions at AAPS PharmSci 360 2026. The conference and trade show will take place October 26-28 in New Orleans, Louisiana, USA. At Booth 1100 in the exhibit hall, Roquette’s Health & Pharma Solutions team will share their expertise across controlled-release technologies, hydroxypropyl beta-cyclodextrins, and sustainable formulation approaches, alongside a comprehensive portfolio of innovative solutions designed to address the evolving needs of pharmaceutical developers. “AAPS PharmSci 360 is a key opportunity to share our latest innovations, as well as highlight the breadth and depth of our scientific know-how that helps our customers solve complex formulation challenges,” said Peter Freed, Head of Technical Service & Development North America for Roquette’s Health & Pharma Solutions Business Unit. “From a
TestGorilla Survey: Recruiters are Faster with AI, but Not More Confident They’re Finding the Right Candidates19.10.2026 15:00:00 CEST | Press release
TestGorilla survey of 1,428 US talent professionalsshows nearly two in three now spend an hour or more manually checking candidates identified by AI AI made finding candidates faster for 72% of US recruiters over the last 12 months, according to TestGorilla's Recruiting in 2026 report, a survey of 1,428 US talent professionals. That speed, however, did not make them any more confident they had found the right person. In fact, of the recruiters that claim AI has made them faster, a third reported no gain in confidence at all, and 18% say their confidence in the match actually fell. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019723138/en/ Recruiters report gains in speed from AI but not in certainty - TestGorilla’s Recruiting in the AI era 2026 report Recruiters are making up the difference themselves, by hand. Of those recruiters, 67% now spend an hour or more manually checking a single candidate before they trust that
Fortanix Announces Confidential AI for Enterprise Grade Kubernetes Workloads on CNCF® Confidential Containers (CoCo)19.10.2026 15:00:00 CEST | Press release
Industry leaders including NVIDIA, Alpha Compute, AMD, Cisco, CrowdStrike, Deepgram, Dell Technologies, Eleven Labs, Fujitsu, Gnani, H2O.ai, HPE, Intel, Klique, Personal AI, Rafay, Red Hat, Resemble AI, Spectro Cloud, Supermicro, Technology Innovation Institute (TII), TELUS and VAST Data support the advancement of secure enterprise AI adoption, enabling enterprises to run frontier AI models, AI agents and AI applications on Kubernetes Fortanix® Inc., a global leader in data and AI security and pioneer of Confidential Computing, today announced support for CNCF Confidential Containers (CoCo) in Fortanix Confidential AI, enabling organizations to run AI workloads on Kubernetes inside hardware-based Trusted Execution Environments (TEEs), on confidential CPUs and GPUs. Enterprises keep the speed and agility of containers while protecting sensitive data, AI models, agents, and applications in use, so they can support their regulatory compliance efforts, scale AI across the business, and ado
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