Alvotech and DKSH have entered into an exclusive license partnership for the commercialization of AVT02, an adalimumab biosimilar, in selected Asia-Pacific 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, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease amongst other indications. It neutralizes tumor necrosis alpha (TNF-α) which is a cytokine involved in the systemic inflammation associated with the labelled indications. Humira recorded sales of about $20 billion in 2018, making it the largest-selling blockbuster medicine worldwide.
 
Under the partnership, Alvotech 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 U.S. Food and Drug Administration (FDA), through Alvotech Hf’s U.S. affiliate.
 
“We are very proud to announce our new partnership with DKSH, a leading healthcare company with deep market experience in Asia,” said Mark Levick, chief executive officer, Alvotech. Through the partnership, Alvotech gains access to DKHS’s strong commercial network, which will ultimately benefit patients who will get better access to high-quality biosimilar medicines.”
 
Bijay Singh, global head of business unit healthcare, DKSH, said, “We see this partnership with Alvotech as a great opportunity to accelerate our development in the biosimilar space and strengthen our position in this fast-growing segment with tremendous promise across Asia. We are extremely excited to soon be able to enrich the lives of Asian patients and their loved ones by providing them with access to a state-of-the-art cost-effective biologic.”