Alvotech, STADA Launch Adalimumab Biosimilar in 7 More European Countries

Iceland-based Alvotech and Germany-based STADA Arzneimittel launched their biosimilar (AVT02) referencing Humira (adalimumab) in 7 countries across Europe: Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.

The launch followed the initial European launch of the same drug in June 2022, during which AVT02 entered the markets in France, Germany, Finland, and Sweden under the name Hukyndra. The companies launched Hukyndra in Switzerland in September 2022. In late November 2022, Alvotech obtained regulatory approval for AVT02 in Australia. AVT02 is also available in Lithuania, Slovakia, Austria, and Estonia.

“Significant unmet needs for access to biologic treatments for autoimmune conditions, including adalimumab, exist for patients across Europe…. Launching adalimumab in further European is evidence of our commitment to broadening patient access to critical therapies. We look forward to working with Alvotech to make high-quality biosimilars available to patients and their caregivers,” said Bryan Kim, head of global specialty care and executive vice president of STADA, in a statement.

AVT02 is the first product launched as part of the 2018 partnership between Alvotech and STADA. An biologics license application for AVT02 is also under review with the FDA, which is reviewing high-concentration and low-concentration citrate-free formulations of the drug as well as an application for interchangeability status. In September, the FDA sent Alvotech a complete response letter stating the manufacturing facility did not pass inspection, postponing the original anticipated approval decision date.

The companies share development and manufacturing responsibilities. STADA holds the marketing authorization and commercialization rights for the products created through the partnership in the European Union, the United States, as well as several countries in the Middle East, North Africa, and Asia-Pacific markets. STADA is also in charge of creating tailored educational materials and dedicated patient-support programs to disseminate in individual national markets.

“We are very pleased with the reception in the European market, and believe the patient-friendly autoinjector design we have introduced supports commercial success. The partnership with STADA continues to broaden access to cost-effective biologics across Europe in line with our shared vision,” commented Anil Okay, chief commercial officer at Alvotech.

In November 2022, the European Commission granted marketing authorization to Alvotech and STADA’s ranibizumab biosimilar (Ximluci) referencing Lucentis for the treatment of ophthalmic conditions. The companies said that they plan to launch Ximluci in early 2023. Alvotech is currently testing a denosumab biosimilar candidate to rival originator Xgeva/Prolia and an aflibercept biosimilar candidate referencing Eylea.