STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases
Esme Needham | December 18, 2025 | News story | Research and Development | Bio-Thera, Immunology, Stada
STADA and Bio-Thera’s Gotenfia (golimumab), a biosimilar of Janssen’s Simponi, has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of various inflammatory autoimmune diseases.
The CHMP’s positive opinion was based on evidence including analytical, non-clinical and clinical data which proved that Gotenfia is biosimilar to its reference product Simponi. The opinion will be referred for the European Commission to grant marketing authorisation for Gotenfia. Marketing authorisation would apply across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.
Following approval, Gotenfia, a monoclonal antibody treatment, would be supplied as 50mg/0.5mL and 100mg/mL in a pre-filled syringe.
STADA and Bio-Thera entered into a license and commercialisation agreement for golimumab in May 2024. Under the terms of this agreement, Bio-Thera is responsible for development, manufacturing and supply, while STADA holds the rights to commercialise the product in the EU, UK, Switzerland and other countries. Earlier this year, the two companies also announced an extension of their collaboration, covering the immunosuppressant monoclonal antibody tocilizumab.
STADA is a pharmaceutical company specialising in consumer healthcare products, generics and specialty pharma. Bio-Thera is a biopharmaceutical company researching and developing treatments for diseases including cancer, autoimmune and cardiovascular, as well as biosimilars.
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