Friday, STADA, a global specialty, generic and consumer healthcare medicines company, and Bio-Thera Solutions, a commercial-stage biopharmaceutical company, have received marketing authorization from the European Commission for their Gotenfia (golimumab) biosimilar referencing Simponi.
The marketing authorization for Gotenfia for several chronic inflammatory autoimmune diseases follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) in December 2025.
Shengfeng Li, CEO of Bio-Thera Solutions, commented, "Building on our prior approvals and launches in the US and EU, this European authorization further establishes Bio-Thera as a major global biosimilar developer and manufacturer."
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