Bio-Thera Solutions, Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE, An Approved Biosimilar Referencing Tocilizumab In Arthritis Research & Therapy
Bio-Thera Solutions, Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE, An Approved Biosimilar Referencing Tocilizumab In Arthritis Research & Therapy
Bio-Thera Solutions和渤健公司發佈了TOFIDENCE的三期臨床試驗數據，TOFIDENCE是參考託珠單抗進行的關節炎研究的批准生物相似藥物。
Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra/RoActemra3 (tocilizumab). BAT1806/BIIB800 is currently commercialized under the brand name TOFIDENCE4.
Bio-Thera Solutions, Ltd.今天宣佈，與Biogen合作在《關節炎研究與治療》雜誌上發表了一項評估BAT1806/BIIB800的3期臨床研究的治療期2（TP2；研究周24-48）的結果，BAT1806/BIIB800是經批准的Actemra/Roactemra3（託珠單抗）生物仿製藥。BAT1806/BIIB800 目前以 TOFIDENCE4 品牌商業化。
- Comparable clinical efficacy and safety in Treatment Period 2 (TP2, Week 24-48) is maintained after switch from reference tocilizumab to TOFIDENCE (BAT1806/BIIB800)
- Phase 3 clinical data in totality demonstrates biosimilarity between TOFIDENCE (BAT1806/BIIB800) and reference tocilizumab before and after switching.1,2
- 從參考託珠單抗改爲TOFIDENCE（BAT1806/BIIB800）後，在治療期 2（TP2，第 24-48 周）中保持了相似的臨床療效和安全性
- 總體而言，3 期臨床數據表明 TOFIDENCE（BAT1806/BIIB800）和參考託珠單抗在切換前後的生物相似性。1,2
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