STADA and Bio-Thera win EC nod for Simponi biosimilar

13 February 2026

German generics and consumer healthcare major STADA Arzneimittel (SAZ: Xetra) and China’s Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, have received a marketing authorization from the European Commission for their Gotenfia (golimumab) biosimilar referencing Simponi, from Johnson & Johnson (NYSE: JNJ).

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