Business
Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion
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, today received a positive opinion from the European Medicines Agency (EMA), recommending approval for their Gotenfia® (golimumab) biosimilar candidate referencing Simponi®.
About this update from Bio-thera Solutions, Ltd. Class A
[{"type":"list","items":[{"val":[{"type":"text","content":"Positive opinion from European Medicines Agency supports approval for golimumab biosimilar Gotenfia® developed by Bio-Thera and to be marketed by STADA","length":161,"tagName":"p"}]},{"val":[{"type":"text","content":"Recommendation from EMA's CHMP committee is based on a robust analytical, non-clinical and clinical data package comparing the biosimilar candidate to the Simponi® reference product","length":195,"tagName":"p"}]},{"val":[{"type":"text","content":"Bio-Thera is responsible for development, manufacturing and supply; STADA for commercialization in the EU, the UK, Switzerland and selected other countries","length":155,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":511,"olType":false},{"type":"text","content":"BAD VILBEL, Germany and GUANGZHOU, China, Dec. 12, 2025 /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, today received a positive opinion from the European Medicines Agency (EMA), recommending approval for their Gotenfia® (golimumab) biosimilar candidate referencing Simponi®.","length":473,"tagName":"p"},{"type":"image","alt":"Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion","displaySize":"","headline":null,"caption":"Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":178,"url":"https://media.zenfs.com/en/prnewswire.com/25fa7cd72ea77134f3076f1af78a84bf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/GDK9D5wRF4d3naYp.NTF9Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTMxNDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/25fa7cd72ea77134f3076f1af78a84bf","width":400,"height":178}},"href":"https://mma.prnewswire.com/media/2844372/Bio_Thera_STADA_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grant a marketing authorization for Gotenfia® for several chronic inflammatory autoimmune diseases: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, no...