Alvotech, STADA launch adalimumab biosimilar in 7 more European countries
In 2014, Iceland-based Alvotech and Germany-based STADA Arzneimittel launched their similar biologic (AVT02) related to Humira (adalimumab). 7 countries across Europe: Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania and Slovenia.
The launch followed the first European launch of the same drug in June 2022, during which the AVT02 entered the markets of France, Germany, Finland and Sweden under the Hukyndra name. The two companies launched Hukyndra in Switzerland September 2022. In late November 2022, Alvotech obtained regulatory approval for the AVT02 in Australia. AVT02 is also available in Lithuania, Slovakia, Austria and Estonia.
“There is a significant unmet need for patients across Europe to access biologic treatments for autoimmune conditions, including adalimumab… The further launch of adalimumab in Europe is a testament to our commitment to expanding patient access to critical therapies. We look forward to working with Alvotech to provide high-quality biosimilars to patients and their caregivers,” Bryan Kim, head of global specialty care and executive vice president of STADA, said in a statement.
The AVT02 is the first product launched as part of the 2018 partnership between Alvotech and STADA. There is also a biologics license application for AVT02 under FDA reviewwhich reviews high- and low-concentration citrate-free drug formulations and an application for interchangeability status. In Septemberthe FDA sent Alvotech a full response stating that the manufacturing facility failed the inspection, pushing back the originally expected approval decision date.
The two companies share responsibility for development and production. STADA has the rights to market and commercialize products created through the partnership in the European Union, the United States of America, and several countries in the Middle East, North Africa, and Asia-Pacific markets. STADA is also tasked with creating customized educational materials and dedicated patient support programs for dissemination in individual national markets.
“We are very pleased with the reception in the European market and believe that the patient-friendly design of the auto-injector we have introduced supports commercial success. The partnership with STADA continues to expand access to cost-effective biologics across Europe in line with our shared vision,” commented Anil Okay, Chief Commercial Officer at Alvotech.
inside November 2022, the European Commission granted marketing authorization to Alvotech and STADA for the similar biologic ranibizumab (Ximluci), which is related to Lucentis for the treatment of ophthalmic conditions. The two companies said they plan to launch Ximluci in early 2023. Alvotech is currently testing a biosimilar denosumab candidate to the competing originator Xgeva/Prolia and an a similar biologic drug candidate, aflibercept mentions Eyle.