Global Drug Development Updates: Alvotech and Celltrion

Last week, Alvotech closed out the year with an announcement that it is expanding its high-tech center in Reykjavik, Iceland.  This high-tech center, which will almost double the size of the existing facility by the end of 2022, will house “biosimilar development, drug refills, offices and warehouse, in addition to facilities that the company will provide to the University of Iceland’s Biotechnology Department.”

Celltrion closed out its year announcing plans for a global phase 3 clinical trial of its ustekinumab biosimilar (CT-P43), aiming to complete the confirmation of CT-P43’s safety and efficacy by the second half of 2022. Ustekinumab is an IL-12, 23 suppress agent used to treat autoimmune diseases, such as psoriasis, Crohn’s disease and ulcerative colitis. Johnson & Johnson’s originator ustekinumab product is called Stelara, and is reported to have earned J&J $6.31 billion in sales last year. Celltion announced that it plans to commercialize CT-P43 when U.S. and European patents on its substance material expire in 2023 and 2024, respectively.