Business
STADA and Bio-Thera receive European Marketing Authorization for Gotenfia, a Biosimilar to Simponi
Global specialty, generic and consumer healthcare medicines company STADA and 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[1] for their Gotenfia® (golimumab) biosimilar referencing Simponi®.
About this update from Bio-thera Solutions, Ltd. Class A
[{"type":"list","items":[{"val":[{"type":"text","content":"European Commission grants approval for Gotenfia®, a golimumab biosimilar to Simponi® that was developed by Bio-Thera and will be marketed by STADA","length":147,"tagName":"p"}]},{"val":[{"type":"text","content":"Launch preparations are underway to bring the second approved golimumab biosimilar to patients across Europe in the coming weeks and months","length":139,"tagName":"p"}]},{"val":[{"type":"text","content":"Bio-Thera is responsible for development, manufacture and supply; STADA for commercialization in the EU, the UK, Switzerland and selected other countries","length":153,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":439,"olType":false},{"type":"text","content":"BAD VILBEL, Germany and GUANGZHOU, China, Feb. 13, 2026 /PRNewswire/ -- Global specialty, generic and consumer healthcare medicines company STADA and 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[1] for their Gotenfia® (golimumab) biosimilar referencing Simponi®.","length":442,"tagName":"p"},{"type":"image","alt":"Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion (PRNewsfoto/Bio-Thera Solutions, Ltd)","displaySize":"","headline":null,"caption":"Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion (PRNewsfoto/Bio-Thera Solutions, Ltd)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":178,"url":"https://media.zenfs.com/en/prnewswire.com/dbb3d33c56b7c7f40a151637db377d46"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/efF9idrFj.VSN3LPpbUvcw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTMxNDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/dbb3d33c56b7c7f40a151637db377d46","width":400,"height":178}},"href":"https://mma.prnewswire.com/media/2756084/Bio_Thera_Solutions_Ltd___STADA.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The authorization of Gotenfia® for several chronic inflammatory autoimmune diseases[2], which applies across the European Union (EU and European Economic Area (EEA), follows a recommendation in December 2025 from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicin...