- Alvotech's AVT02 is being developed as a biosimilar of the HUMIRA(R) 
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

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(R) biosimilar candidate. The objective of the study is to 
compare AVT02 and HUMIRA(R) 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(R) 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-a) 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."

About Alvotech 

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:

About biosimilars:

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.[1] 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.[2]

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]

Media enquires: 
Halldor Kristmannsson 
Corporate Communications  
Halldor.kristmannsson@alvotech.com     
+3548403425

Source: Alvotech