Alvotech Announces Expected Global Market Entry Dates for Biosimilar to Stelara

Alvotech recently announced it has reached settlement agreements with Johnson & Johnson in Japan, Canada, and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara (ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for AVT04 are currently pending in additional global markets, including in the US.

Market entry of AVT04 in Canada is expected in Q1 2024. Launch of AVT04 in Japan is anticipated after the upcoming round of National Health Insurance reimbursement price listings, in May 2024. Entry to the first European markets is expected as soon as possible after the expiration date of the European Supplementary Protection Certificate (SPC) for Stelara, which is in late July 2024.

“We look forward to working with our commercial partners in launching the first biosimilar to Stelara in these global markets, thereby increasing patient access to a vital biologic,” said Robert Wessman, Chairman and CEO of Alvotech.

Market authorization for AVT04 in Japan is held by Alvotech’s commercial partner Fuji Pharma Co. Ltd., where the biosimilar will be marketed as Ustekinumab BS (F). Alvotech’s commercial partner and market authorization holder for AVT04 in Canada is JAMP Pharma Group, where the biosimilar will be marketed as Jamteki. In the EEA, Alvotech’s commercial partner and market authorization holder for AVT04 is STADA Arzneimittel AG, where the trade name for AVT04 will be Uzpruvo.

In June 2023, Alvotech and Teva, the commercialization partner for AVT04 in the US, reached a settlement and license agreement with Johnson & Johnson, that grants an entry date for AVT04 in the US no later than February 21, 2025, pending approval of the Biologics License Application by the US FDA, which is expected by the Biosimilar User Fee Act goal date of April 16, 2024.

AVT04 is a monoclonal antibody and a biosimilar of Stelara (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. AVT04 has been approved in Japan, Canada, and the EEA, which includes in the 27 member states of the European Union, as well as Norway, Iceland, and Liechtenstein. Market applications are pending in other global markets, including the US.

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, visit www.alvotech.com.