AVT02 is a mAb biosimilar to AbbVie's HUMIRA, which is a leading drug indicated 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 neutralizes the Tumor Necrosis Alpha (TNF- involved in systemic inflammation and the above-mentioned diseases. AbbVie's HUMIRA recorded sales of about US$20 billion in 2018, making it the largest-selling blockbuster medicine worldwide.
Under the partnership, Alvotech will be responsible for development and supply of the product, while Cipla Gulf will be responsible for registration and commercialization. Alvotech's AVT02 is in Phase-3 clinical development ahead of filing with the European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) by early 2020.
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