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
Rapid Medical™’s DISTALS Trial Overwhelmingly Positive, Demonstrating Superior Reperfusion with TIGERTRIEVER™ 13 in Medium Vessel Stroke6.2.2026 20:30:00 CET | Press release
TIGERTRIEVER™ 13 is the first device shown to meet safety and effectiveness endpoints for restoring blood flow in smaller but critical areas of the brain, accounting for almost 50% of all ischemic strokes Rapid Medical™, a leading developer of active endovascular devices, today announced late-breaking results from the DISTALS multicenter, randomized controlled trial showing that TIGERTRIEVER™ 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke. The findings were presented in the main closing session at the 2026 International Stroke Conference (ISC). Top-line results showed that the TIGERTRIEVER™ 13 arm demonstrated 3x more successful reperfusion without symptomatic intracranial hemorrhage (sICH) compared to medical management–86.3% vs 27.7% (p < 0.001). Notably, zero sICH events were reported in the randomized treatment arm treated with TIGERTRIEVER 13. By comparison, sICH rates rep
Al Barari Breaks Ground on The Cape, The Final Chapter of a Legacy6.2.2026 15:46:00 CET | Press release
Al Barari, Dubai’s pioneering nature-led community, has officially marked the groundbreaking of The Cape, its final signature residential development, celebrating two decades of visionary craftsmanship and a continued commitment to creating harmonious living environments rooted in nature. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260206475199/en/ Hazza Zaal, CEO of Al Barari Real Estate Group, alongside the Sales and Construction teams at The Cape Groundbreaking Ceremony, marking a milestone in Al Barari’s final signature development. (Photo: AETOSWire) The milestone ceremony signals the beginning of a landmark chapter for Al Barari, as The Cape represents the culmination of a 20-year legacy defined by intentional design, wellbeing-focused living, and immersive natural landscapes. Located within Dubai’s green heart, The Cape introduces an enriched lifestyle experience surrounded by lush botanical settings, gentle water
Andersen Consulting indgår samarbejdsaftale med Alfa Group6.2.2026 15:41:00 CET | Pressemeddelelse
Andersen Consulting styrker sit udbud inden for cybersikkerhed gennem samarbejdet med Alfa Group, der er en førende teknologivirksomhed med næsten tre årtiers erfaring i at hjælpe organisationer med at beskytte og optimere deres drift. Alfa Group blev grundlagt i 1996 og har hovedsæde i Rom. Virksomheden leverer avancerede løsninger inden for cybersikkerhed, registrering og forebyggelse af svindel, hændelseshåndtering og sårbarhedsstyring samt udvalgte ydelser inden for processtyring. Deres proprietære teknologi, N.O.V.A., er en fuldt integreret administreret tjeneste, der kombinerer Alfa Groups innovationer med tredjepartssystemer for at beskytte digitale infrastrukturer, reducere risici og øge den operationelle effektivitet. Virksomheden betjener kunder på tværs af brancher, herunder finans og forsikring, forsvar og rumfart, telekommunikation, fremstilling, energi og medicinalindustrien. "Vores samarbejde med Andersen Consulting giver os mulighed for at udvide vores rækkevidde og lev
Quantfury and Sandwich Launch Commercial Series to Encourage Better Choices in Retail Trading6.2.2026 15:00:00 CET | Press release
Quantfury Trading Americas Limited (“Quantfury”), a global brokerage offering commission-free trading at real-time spot prices from major exchanges, has partnered with Sandwich, a leading creative agency for tech and product videos, to produce a Social Responsibility Commercial Series. The series of commercials incorporates clear, engaging storytelling to prompt viewers to think about common retail trading behaviors—especially high-energy marketing, gamification of speculation, and heavy focus on potential gains without equal attention to risks—and to choose more thoughtful, informed approaches. Lev Mazur, Founder of Quantfury, said: “It’s a pleasure to work with Sandwich, whose visual storytelling is outstanding. Since day one, Quantfury has aimed to question and improve the standard practices in the global retail trading industry.” Adam Lisagor, Founder of Sandwich, added: “A good investment is a story. Quantfury stood out by wanting to tell a real, interesting story first—rather tha
JSS: 2025 Sake Exports Grew Steadily, Reaching a Record 81 Markets6.2.2026 04:00:00 CET | Press release
Sake exports continued to expand in 2025 in both value and volume, with export destinations reaching a record 81 countries and regions. Export value increased 6% year on year to 45.9 billion yen, while export volume rose 8% to 33.55 million liters (3.73 million cases on a 9-liter basis), marking the second-highest export performance on record. The average export unit price per 750 ml bottle declined 2% year on year to 1,026 yen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205671686/en/ Sake Export Performance by Country (Top 10, 2025) Export value has nearly doubled since 2020, and the CAGR over the past five years reached 14%. This underscores sake’s position as a high-growth category globally. Asia remained the largest export destination, with export value totaling 28.8 billion yen, representing an 8% increase year on year and accounting for 63% of total export value. North America recorded exports of 12.4 billion ye
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