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
Andersen Consulting tilføjer Multiplica3.4.2026 13:30:00 CEST | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Multiplica, et digitalt konsulentfirma, der hjælper organisationer med at designe, bygge og skalere effektfulde digitale oplevelser. Multiplica, der er stiftet i Spanien og desuden har aktiviteter i Latinamerika og USA, fokuserer på brugerundersøgelser og behovsafdækning, research af kundeoplevelser, digital strategi, datamodellering og -analyse, rapportautomatisering og datavisualisering, konverteringsoptimering, produktdesign og design af brugeroplevelser. Virksomheden hjælper organisationer med at fremskynde den digitale transformation ved at opbygge digitale kompetencer, teams og aktiver, der fremmer ekspertise på tværs af digitale produkter, rådgivning og talentudvikling. Multiplica gør det muligt for kunder at prognosticere nye tendenser inden for digitale oplevelser og transformere deres forretninger gennem styrkede digitale kanaler og kundeengagement. "Samarbejdet med Andersen Consulting udgør en spændende mulighed for at udvid
Enry’s Island Unveils “Enry’s Island Adventures”: Venture Capital Becomes a Videogame and Launches the “Strap” Movement on Kickstarter3.4.2026 09:47:00 CEST | Press release
Gaming, finance, and lifestyle merge to democratize the startup ecosystem: Enry’s Island opens 2026 applications for game development studios seeking more than just capital. Enry’s Island SpA (WBAG: EIOS), the world’s first publicly traded Venture Builder, today announced the upcoming Kickstarter launch of Enry’s Island Adventures (EIA), developed by its New York-based portfolio company, Enry’s Island Adventures LLC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402548535/en/ The game is designed to make venture capital accessible to new generations, transforming startup creation into an engaging and social gaming experience. After three years of R&D, EIA introduces a "bleisure" model (business + leisure): players learn to launch and manage startups through gameplay that includes real business KPIs, a customizable and evolving personal island, synchronous and asynchronous multiplayer modes, social events, and community-d
SES Announces Results of the Annual General Meeting2.4.2026 16:49:00 CEST | Press release
SES (the “Company”) held the Annual General Meeting (“AGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions, including the Company’s 2025 annual accounts and the proposed annual dividend of EUR 0.50 per A-share (EUR 0.20 per B-share). The total dividend amount comprises the interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share), which has already been paid to shareholders on October 16, 2025. The final dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) will be paid to shareholders on April 16, 2026. “I would like to sincerely thank our shareholders for their active engagement, visionary support and continued confidence in SES’ strategy,” said Adel Al-Saleh, CEO of SES. “The outcomes of today’s AGM underscore our shared commitment to a bold multi-orbit approach, with Medium Earth Orbit as the strategic backbone of a dynamically evolving global interco
Andersen Consulting styrker sine kompetencer med tilføjelsen af Lukkap2.4.2026 16:31:00 CEST | Pressemeddelelse
Andersen Consulting tilføjer samarbejdspartneren Lukkap, et konsulenthus med fokus på oplevelsesdrevne kompetencer, der er tilpasset kundernes skiftende behov inden for transformation af medarbejdere, kunder og det digitale område. Lukkap, der blev stiftet i 2009 og har hovedsæde i Spanien, leverer integrerede løsninger, der hjælper organisationer med at transformere, hvordan de betjener kunder, engagerer medarbejdere og frigør værdi gennem adfærdsindsigt og dataanalyse. Virksomhedens tværfaglige tilgang spænder over nytænkning af kunderejsen, effektive programmer for medarbejderoplevelser, talent- og ledelsesudvikling, prædiktiv analyse samt omfattende outplacement- og transitionsydelser. Lukkap arbejder på tværs af sektorer — herunder sundhedsvæsen, medicinalindustri, forbrugsgoder, detailhandel, finans og bankvæsen — for at opbygge menneskecentrerede strategier, der skaber målbare forretningsresultater. "Ved at kombinere vores erfaringsdrevne metode med Andersen Consultings globale
Forrester: Three Years Into GenAI, Enterprises Are Still Chasing Its True Transformative Value2.4.2026 16:00:00 CEST | Press release
Low AI fluency, uneven adoption, and marginal productivity gains are limiting enterprise-scale impact According to Forrester’s (Nasdaq: FORR) latest report, Accelerate Your AI Voyage, most enterprises are struggling to turn growing AI adoption and investment into measurable business impact. One of the key factors holding businesses back is low artificial intelligence quotient (AIQ) — Forrester’s measure of AI aptitude — with many employees lacking a clear understanding of how to use AI. Other barriers include an overemphasis on productivity-focused use cases, difficulty measuring impact, and siloed adoption within individual functions. While these challenges can leave firms frozen in doubt or indecision, the wait-and-see approach to AI adoption is no longer viable. To unlock AI’s full potential, organizations need to focus on four key areas: Define the business outcomes and success metrics for what they want AI to achieve; identify specific use cases for AI deployment aligned to those
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