Biopharmaceutical company Alvotech and Indian generics developer Cipla have entered an exclusive partnership for the commercialization of AVT02 (adalimumab), a monoclonal antibody (mAb) biosimilar to Humira, a blockbuster drug marketed by AbbVie.
Humira, which recorded sales of approximately $20bn (€17.98bn) in 2018 for AbbVie, is indicated for several autoimmune diseases, such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and Crohn's disease.
Alvotech and Cipla aim to enter the market with AVT02, though they will potentially enter with a number of existing competitors – following in the development footsteps of other companies with biosimilar drugs to Humira, including Mylan, Samsung Bioepis, Amgen, Sandoz and Boehringer Ingelheim.
Under the agreement, Alvotech will be responsible for the development and supply of the product, while Cipla, through its subsidiary, Cipla Gulf, will be responsible for registration and commercialization.
AVT02 is currently in Phase III clinical trials and the company announced plans to file with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for approval by early 2020.
Nishant Saxena, CEO of Cipla, commented on the agreement, saying that adalimumab will be a ‘significant addition’ to the company’s portfolio, as it is “the highest-selling pharmaceutical product in the world and the preferred anti-inflammatory treatment option for several autoimmune diseases.”