Alvotech Hf and DKSH, a leading healthcare provider across 36 emerging countries in South-East Asia, today announced that Alvotech Hf and DKSH have entered into an exclusive license partnership for the commercialization of AVT02, an adalimumab biosimilar, in selected APAC markets.
AVT02 is a biosimilar monoclonal antibody to AbbVie’s HUMIRA®, which is a leading drug indicated for the treatment of several autoimmune diseases, including Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Plaque Psoriasis (PP), Psoriatic Arthritis, Ulcerative Colitis (UC), and Crohn’s Disease (CD) amongst other indications. It neutralizes Tumor Necrosis Alpha (TNF-α) which is a cytokine involved in the systemic inflammation associated with the labelled indications. AbbVie’s HUMIRA® recorded sales of about US$20 billion in 2018, making it the largest-selling blockbuster medicine worldwide.
Under the partnership, Alvotech Hf will be responsible for the development and supply of AVT02, while DKSH will be responsible for its registration and commercialization.
AVT02 will be filed in the second half of 2020 with the European Medicines Agency (EMA) and with United States Food and Drug Administration (USFDA) (through Alvotech Hf’s US affiliate).