Alvotech and Cipla Gulf in deal for Humira biosimilar

Privately-held Icelandic company Alvotech and a unit of India’s Cipla (BSE: 500087) have entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets.

AVT02 is a monoclonal antibody (MAb) biosimilar to AbbVie's (NYSE ABBV) Humira, which is the world’s top-selling drug indicated for the treatment of several autoimmune diseases, with the branded drug generated sales of around $20 billion for AbbVie in 2018.

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 III clinical development ahead of filing with the European Medicines Agency and US Food and Drug Administration by early 2020 and, if approved, will add to a string of Humira biosimilars that have been cleared for marketing in both regions, though none have yet been launched in the USA, where AbbVie has entered into various agreements to stave off competition until June 2023.