Alvotech Enrolls First Patient in Clinical Phase III Study Involving Biosimilar Version of HUMIRA®
Alvotech's AVT02 is being developed as a biosimilar of the HUMIRA® high-concentration (100mg/mL) product, expected to be more convenient for patients, compared to biosimilar competitors
400 participants to be enrolled in Phase III study at 30 sites across Europe
Phase I PK comparability study for AV02 is also ongoing
13 Mar, 2019, 05:00 ET
REYKJAVIK, Iceland, March 13, 2019 /PRNewswire/ -- Global biopharmaceutical company Alvotech today announced that it has enrolled the first patient in its Phase III clinical study (ALVOPAD PS) involving AVT02, Alvotech's HUMIRA® biosimilar candidate. The objective of the study is to compare AVT02 and HUMIRA® in terms of safety, efficacy, tolerability and immunogenicity in adult patients with moderate to severe chronic plaque psoriasis.
The study is expected to enroll 400 participants at approximately 30 sites in Europe. The AVT02 formulation contains a high concentration (100 mg/ml) of adalimumab, which is expected to be more convenient for patients, for example, based on the reduced injection volume. With AVT02, Alvotech is well positioned to differentiate from biosimilars competitors.
HUMIRA® is a leading drug for the treatment of several autoimmune diseases, including (but not limited to) Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Plaque Psoriasis (PP), Psoriatic Arthritis, Ulcerative Colitis (UC), and Crohn's Disease (CD). It inhibits the Tumor Necrosis Alpha (TNF-α) involved in systemic inflammation involved with the above-mentioned diseases. Abbvie's HUMIRA® recorded sales of about US$20 billion in 2018, making it the largest-selling blockbuster medicine worldwide.
Robert Wessman, founder and chairman of the board, said: "We are delighted that, after intensive preparation, our first biosimilar product has enrolled its first patient. It is a major step forward in the development of our biosimilars portfolio. By developing a high-quality and cost-effective biosimilar, we seek to give as many patients as possible the opportunity to access this treatment option and we provide an opportunity for healthcare providers around the world to improve patient care and significantly reduce costs. With a fully integrated approach, a state-of-the-art biopharmaceutical facility, and state-of-the-art development centers, Alvotech is well positioned to take on opportunities in the global biosimilars market."
Dr. Fausto Berti, Alvotech SVP and head of clinical and late stage development at Alvotech, added: "We are pleased that the first patient has now been enrolled in the ALVOPAD PS study (AVT02-GL-301), and we look forward to continued recruitment and patient follow-up. We are also enthusiastic about the Phase I pharmacokinetic study (AVT02-GL-101) in healthy volunteers that is ongoing in Australia and New Zealand." "The initiation of this Phase III study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases by providing high-quality biosimilars. Specifically, with AVT02 containing biosimilar adalimumab at high concentration (100 mg/ml), we hope to reach future patients with a more convenient, cost-effective version of adalimumab."
Alvotech is a privately-owned biopharmaceutical company focused on developing and manufacturing high quality biosimilars for markets worldwide. Alvotech has a clear focus on biosimilar product creation, and Alvotech controls the entire value chain from cell line development through commercial manufacturing. Our current pipeline consists of six biosimilar monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases. We are specialists in biotechnology; we are working to be a global leader in the biosimilars space and to deliver high quality cost competitive products and services to our partners and to patients worldwide.
Additional information for journalists:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases, such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biopharmaceuticals will lose their patent protection – and by 2020, medications with revenues of more than US$100 billion will be off patent.
Biosimilars are follow-on versions of biopharmaceuticals. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, China, Canada, and Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently more than US$5.0 billion, industry experts expect this figure to grow up to US$30 billion by the year 2025.
About Plaque Psoriasis
Psoriasis is an immune-mediated disease that causes raised, red, scaly patches to appear on the skin. Accounting for approximately 80%-90% of cases it is the most common form of psoriasis.2 Common sites of the disease include elbows, knees, scalp and lower back, but affected areas can appear anywhere on the body.
1. National Psoriasis Foundation, 'About Psoriasis'. [Online] Available at: https://www.psoriasis.org/about-psoriasis [Accessed: Mar 2019].
2. American Academy of Dermatology, 'Psoriasis'. [Online] Available at: https://www.aad.org [Accessed: Mar 2019]
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